Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function
NCT ID: NCT00094302
Last Updated: 2015-03-02
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
3445 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-08-31
Study Completion Date
2013-06-30
Brief Summary
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The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.
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Detailed Description
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BACKGROUND:
Heart failure (HF) is a major cause of morbidity and mortality, particularly in older people. Indeed, it is the most common discharge diagnosis in patients older than 65 years. As the United States population ages, heart failure will continue to grow as a public health concern. Therapeutic trials of heart failure have dealt almost exclusively with patients who have systolic dysfunction. However, there is now an emerging awareness that nearly half of the patients with heart failure have preserved systolic function and that the survival of these patients is adversely affected. This study is a randomized clinical trial of a novel therapeutic approach, specifically the use of spironolactone, an aldosterone antagonist, in treating these patients. While this treatment has been shown to be useful in treating heart failure with reduced systolic function, it has not been studied in patients with preserved systolic function.
Patients with heart failure and preserved systolic function have a poor prognosis. The annual mortality rate is intermediate between the prognosis for those without heart failure and for those with heart failure and reduced systolic function. For instance, Family Health Study participants with heart failure and preserved systolic function had a mortality rate of 9% compared to 3% for their age- and gender-matched controls. The mortality rate was 19% in heart failure patients with reduced systolic function heart failure compared to 4% for their matched controls.
As heart failure develops, neurohormones are released that initially improve cardiac output but ultimately contribute to progression of left ventricular dysfunction. The renin-angiotensin-aldosterone system is an important part of this compensatory response. Aldosterone levels may rise to 20 times normal levels in heart failure and aldosterone contributes to the development of myocardial fibrosis. Spironolactone is a potassium-sparing diuretic that acts on the distal tubule, inhibiting sodium and potassium ion exchange. There are several potential beneficial actions, including prevention of cardiac fibrosis. A recent trial evaluated spironolactone in patients with systolic dysfunction heart failure. Spironolactone treatment caused a 30% reduction in mortality compared to placebo (p\< 0.001). The improvement resulted from a reduction in all cause mortality. More recently, the Eplerenone Post-Myocardial Infarction (MI) study showed that this aldosterone antagonist significantly reduces mortality despite background treatment with an angiotensin-converting enzyme (ACE) inhibitor and beta-blocker. Advantages of using spironolactone in this study are that it is commercially available, inexpensive, and no longer under patent (therefore this study will not be done by industry). Also, there is a clear physiologic rationale for its use, and the side effect profile is well understood. The study enrolled subjects who had preserved systolic function with heart failure and who met clearly defined eligibility criteria that were selected to make the results widely generalizable to clinical practice.
DESIGN NARRATIVE:
This is a randomized, double-blinded, placebo-controlled trial of aldosterone antagonist therapy (15 mg dose spironolactone or placebo; titrated up to 30 or 45 mg/day) in 3,445 adult patients with heart failure and preserved systolic function. Patients were recruited from August 2006 through January 2012, treated, and will be followed through June 2013. Approximately 270 clinical sites in six countries were subcontracted by the clinical trial coordinating center. Subject visits to a clinical center will occur every four or six months. Data collected include demographic and clinical data, including the results of history and physical exams, laboratory and imaging data, repository specimens for special physiology studies, and genetic studies. Additionally, data regarding quality of life and compliance with assigned treatment will also be collected and assessed.
Heart failure (HF) is a major cause of morbidity and mortality, particularly in older people. Indeed, it is the most common discharge diagnosis in patients older than 65 years. As the United States population ages, heart failure will continue to grow as a public health concern. Therapeutic trials of heart failure have dealt almost exclusively with patients who have systolic dysfunction. However, there is now an emerging awareness that nearly half of the patients with heart failure have preserved systolic function and that the survival of these patients is adversely affected. This study is a randomized clinical trial of a novel therapeutic approach, specifically the use of spironolactone, an aldosterone antagonist, in treating these patients. While this treatment has been shown to be useful in treating heart failure with reduced systolic function, it has not been studied in patients with preserved systolic function.
Patients with heart failure and preserved systolic function have a poor prognosis. The annual mortality rate is intermediate between the prognosis for those without heart failure and for those with heart failure and reduced systolic function. For instance, Family Health Study participants with heart failure and preserved systolic function had a mortality rate of 9% compared to 3% for their age- and gender-matched controls. The mortality rate was 19% in heart failure patients with reduced systolic function heart failure compared to 4% for their matched controls.
As heart failure develops, neurohormones are released that initially improve cardiac output but ultimately contribute to progression of left ventricular dysfunction. The renin-angiotensin-aldosterone system is an important part of this compensatory response. Aldosterone levels may rise to 20 times normal levels in heart failure and aldosterone contributes to the development of myocardial fibrosis. Spironolactone is a potassium-sparing diuretic that acts on the distal tubule, inhibiting sodium and potassium ion exchange. There are several potential beneficial actions, including prevention of cardiac fibrosis. A recent trial evaluated spironolactone in patients with systolic dysfunction heart failure. Spironolactone treatment caused a 30% reduction in mortality compared to placebo (p\< 0.001). The improvement resulted from a reduction in all cause mortality. More recently, the Eplerenone Post-Myocardial Infarction (MI) study showed that this aldosterone antagonist significantly reduces mortality despite background treatment with an angiotensin-converting enzyme (ACE) inhibitor and beta-blocker. Advantages of using spironolactone in this study are that it is commercially available, inexpensive, and no longer under patent (therefore this study will not be done by industry). Also, there is a clear physiologic rationale for its use, and the side effect profile is well understood. The study enrolled subjects who had preserved systolic function with heart failure and who met clearly defined eligibility criteria that were selected to make the results widely generalizable to clinical practice.
DESIGN NARRATIVE:
This is a randomized, double-blinded, placebo-controlled trial of aldosterone antagonist therapy (15 mg dose spironolactone or placebo; titrated up to 30 or 45 mg/day) in 3,445 adult patients with heart failure and preserved systolic function. Patients were recruited from August 2006 through January 2012, treated, and will be followed through June 2013. Approximately 270 clinical sites in six countries were subcontracted by the clinical trial coordinating center. Subject visits to a clinical center will occur every four or six months. Data collected include demographic and clinical data, including the results of history and physical exams, laboratory and imaging data, repository specimens for special physiology studies, and genetic studies. Additionally, data regarding quality of life and compliance with assigned treatment will also be collected and assessed.
Conditions
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Cardiovascular Diseases
Heart Diseases
Heart Failure, Congestive
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Placebo
Placebo of spironolactone
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo of spironolactone
Spironolactone
Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Group Type
EXPERIMENTAL
Spironolactone
Intervention Type
DRUG
Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Interventions
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Spironolactone
Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
Intervention Type
DRUG
Placebo
Placebo of spironolactone
Intervention Type
DRUG
Other Intervention Names
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aldosterone antagonist
Eligibility Criteria
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Inclusion Criteria
* Heart failure as defined by at least one of symptom (paroxysmal nocturnal dyspnea; orthopnea; or dyspnea on mild or moderate exertion) at the time of screening and at least one sign (any rales post cough; jugular venous pressure(JVP) greater than or equal to 10cm of water(H2O); lower extremity edema; or chest x-ray demonstrating pleural effusion, pulmonary congestion, or cardiomegaly) within 12 months prior to study entry:
* left ventricular ejection fraction greater than or equal to 45% (per local reading); the ejection fraction must have been obtained within 6 months prior to randomization and after any MI or other event that would affect ejection fraction
* Controlled systolic blood pressure(BP), defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP
* Serum potassium less than 5.0 mmol/L prior to randomization
* At least one hospital admission for which heart failure was a major component of the hospitalization some time within the 12 months prior to study entry OR brain natriuretic peptide (BNP) greater than or equal to 100pg/ml or N-terminal pro-BNP greater than or equal to 360pg/ml within the 60 days prior to study entry
* Women of child-bearing potential must have a negative serum/urine pregnancy test within 72 hours prior to randomization, must not be lactating, and must agree to use an effective method of contraception during the entire course of study participation
* Willing to comply with scheduled visits
* Informed consent form signed by the subject prior to participation in the trial
* left ventricular ejection fraction greater than or equal to 45% (per local reading); the ejection fraction must have been obtained within 6 months prior to randomization and after any MI or other event that would affect ejection fraction
* Controlled systolic blood pressure(BP), defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP
* Serum potassium less than 5.0 mmol/L prior to randomization
* At least one hospital admission for which heart failure was a major component of the hospitalization some time within the 12 months prior to study entry OR brain natriuretic peptide (BNP) greater than or equal to 100pg/ml or N-terminal pro-BNP greater than or equal to 360pg/ml within the 60 days prior to study entry
* Women of child-bearing potential must have a negative serum/urine pregnancy test within 72 hours prior to randomization, must not be lactating, and must agree to use an effective method of contraception during the entire course of study participation
* Willing to comply with scheduled visits
* Informed consent form signed by the subject prior to participation in the trial
Exclusion Criteria
* Severe systemic illness with an expected life expectancy of less than 3 years
* Chronic pulmonary disease requiring home O2, oral steroid therapy, or hospitalization for exacerbation within 12 months of study entry, or significant chronic pulmonary disease in the opinion of the investigator
* Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction
* Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
* Atrial fibrillation with a resting heart rate greater than 90 bpm
* MI in the past 90 days
* Coronary artery bypass graft surgery in the past 90 days
* Percutaneous coronary intervention in the past 30 days
* Heart transplant recipient
* Currently implanted left ventricular assist device
* Stroke in past 90 days
* Systolic BP (SBP) greater than 160 mm Hg
* Known orthostatic hypotension
* Gastrointestinal disorder that could interfere with study drug absorption
* Use of any aldosterone antagonist or potassium sparing medication in the last 14 days or any known condition that would require the use of an aldosterone antagonist during study participation;
* Known intolerance to aldosterone antagonists
* Current lithium use
* Current participation (including prior 30 days) in any other therapeutic trial
* Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol
* History of hyperkalemia (serum potassium greater than or equal to 5.5mmol/L) in the past 6 months or serum potassium greater than or equal to 5.0mmol/L within the past 2 weeks
* Severe renal dysfunction, defined as an estimated glomerular filtration rate(GFR) less than 30ml/min. Participants with serum creatinine greater than or equal to 2.5mg/dl are also excluded even if their GFR is greater than or equal to 30ml/min
* Known chronic hepatic disease, defined as aspartate aminotransferase(AST) and alanine aminotransferase(ALT) levels greater than 3.0 times the upper limit of normal as read at the local lab.
* Chronic pulmonary disease requiring home O2, oral steroid therapy, or hospitalization for exacerbation within 12 months of study entry, or significant chronic pulmonary disease in the opinion of the investigator
* Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction
* Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
* Atrial fibrillation with a resting heart rate greater than 90 bpm
* MI in the past 90 days
* Coronary artery bypass graft surgery in the past 90 days
* Percutaneous coronary intervention in the past 30 days
* Heart transplant recipient
* Currently implanted left ventricular assist device
* Stroke in past 90 days
* Systolic BP (SBP) greater than 160 mm Hg
* Known orthostatic hypotension
* Gastrointestinal disorder that could interfere with study drug absorption
* Use of any aldosterone antagonist or potassium sparing medication in the last 14 days or any known condition that would require the use of an aldosterone antagonist during study participation;
* Known intolerance to aldosterone antagonists
* Current lithium use
* Current participation (including prior 30 days) in any other therapeutic trial
* Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol
* History of hyperkalemia (serum potassium greater than or equal to 5.5mmol/L) in the past 6 months or serum potassium greater than or equal to 5.0mmol/L within the past 2 weeks
* Severe renal dysfunction, defined as an estimated glomerular filtration rate(GFR) less than 30ml/min. Participants with serum creatinine greater than or equal to 2.5mg/dl are also excluded even if their GFR is greater than or equal to 30ml/min
* Known chronic hepatic disease, defined as aspartate aminotransferase(AST) and alanine aminotransferase(ALT) levels greater than 3.0 times the upper limit of normal as read at the local lab.
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
Carelon Research
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Sonja M. McKinlay, PhD
Role: PRINCIPAL_INVESTIGATOR
New England Research Institutes, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Site Status
Cardiovascular Consultants, Ltd.
Glendale, Arizona, United States
Site Status
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States
Site Status
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States
Site Status
Heart Clinic Arkansas
Little Rock, Arkansas, United States
Site Status
Cynthia Thaik
Burbank, California, United States
Site Status
Fresno VA Medical Center
Fresno, California, United States
Site Status
Clinica Medica San Miguel
Los Angeles, California, United States
Site Status
CAPRI
Los Angeles, California, United States
Site Status
VA Medical Center West Los Angeles
Los Angeles, California, United States
Site Status
Mehrdad Kevin Ariani, MD, Inc.
Northridge, California, United States
Site Status
UC Davis Medical Center
Sacremento, California, United States
Site Status
Central Coast Cardiology
Salinas, California, United States
Site Status
Naval Medical Center San Diego
San Diego, California, United States
Site Status
Olive View - UCLA Medial Center
Sylmar, California, United States
Site Status
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Site Status
Cardio-Vascular Institute
Greeley, Colorado, United States
Site Status
University of Connecticut Health Center
Farmington, Connecticut, United States
Site Status
Washington Hospital Center
Washington D.C., District of Columbia, United States
Site Status
Howard University Hospital
Washington D.C., District of Columbia, United States
Site Status
Washington DC VA Hospital
Washington D.C., District of Columbia, United States
Site Status
Daytona Heart Group
Daytona Beach, Florida, United States
Site Status
M & O Clinical Research, LLC
Fort Lauderdale, Florida, United States
Site Status
Florida Heart Center
Ft. Pierce, Florida, United States
Site Status
University of Florida
Gainesville, Florida, United States
Site Status
Mayo Clinic Florida
Jacksonville, Florida, United States
Site Status
Brevard Cardiovascular Research Associates, Inc
Rockledge, Florida, United States
Site Status
Tallahassee Research Institute
Tallahassee, Florida, United States
Site Status
Emory University at Grady Health System
Atlanta, Georgia, United States
Site Status
Morehouse School of Medicine
Atlanta, Georgia, United States
Site Status
Northside Cardiology Center
Atlanta, Georgia, United States
Site Status
InnovaMed Alliance
Marietta, Georgia, United States
Site Status
Rush University Medical Center
Chicago, Illinois, United States
Site Status
University of Illinois at Chicago Medical Center
Chicago, Illinois, United States
Site Status
Northwestern University
Chicago, Illinois, United States
Site Status
Cardiovascular Research Foundation
Elk Grove Village, Illinois, United States
Site Status
Heart, Lung and Vascular Institute
Peoria, Illinois, United States
Site Status
HeartCare Midwest
Peoria, Illinois, United States
Site Status
The Care Group, LLC
Indianapolis, Indiana, United States
Site Status
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, United States
Site Status
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Site Status
Baptist Healthcare System, Inc. d/b/a Baptist Hospital East
Louisville, Kentucky, United States
Site Status
Leonard J. Chabert Medical Center
Houma, Louisiana, United States
Site Status
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Site Status
Northeast Cardiology
Bangor, Maine, United States
Site Status
University of Maryland Medical Center
Baltimore, Maryland, United States
Site Status
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Site Status
Kaiser Permanente
Largo, Maryland, United States
Site Status
Northwest Hospital
Randallstown, Maryland, United States
Site Status
Delmarva Heart Research Foundation
Salisbury, Maryland, United States
Site Status
Associates in Cardiology, PA
Silver Spring, Maryland, United States
Site Status
Brigham and Women's Hospital
Boston, Massachusetts, United States
Site Status
Boston University Medical Center
Boston, Massachusetts, United States
Site Status
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Site Status
Merrimack Valley Cardiology Associates
Chelmsford, Massachusetts, United States
Site Status
Compass Medical East Bridgewater
East Bridgewater, Massachusetts, United States
Site Status
Pentucket Medical Associates
Haverhill, Massachusetts, United States
Site Status
Charles River Medical Associates
Natick, Massachusetts, United States
Site Status
Hawthorn Medical Associates
North Dartmouth, Massachusetts, United States
Site Status
Baystate Medical Center
Springfield, Massachusetts, United States
Site Status
Umass Memorial Medical Center
Worcester, Massachusetts, United States
Site Status
Veterans Affairs Ann Arbor Health Care System
Ann Arbor, Michigan, United States
Site Status
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Site Status
Detroit VA Medical Center
Detroit, Michigan, United States
Site Status
Henry Ford Hospital
Detroit, Michigan, United States
Site Status
William Beaumont Health Center
Royal Oak, Michigan, United States
Site Status
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States
Site Status
Heartland Regional Medical Clinic
Saint Joseph, Missouri, United States
Site Status
Glacier View Cardiology
Kalispell, Montana, United States
Site Status
Bryan LGH Heart Institute
Lincoln, Nebraska, United States
Site Status
The Creighton Cardiac Center
Omaha, Nebraska, United States
Site Status
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Site Status
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, United States
Site Status
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
Site Status
NJ Heart
Linden, New Jersey, United States
Site Status
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States
Site Status
The Valley Hospital
Ridgewood, New Jersey, United States
Site Status
Electrophysiology Research Foundation
Somerset, New Jersey, United States
Site Status
Community Medical Center
Toms River, New Jersey, United States
Site Status
New Jersey Cardiology Associates
West Orange, New Jersey, United States
Site Status
New York Methodist Hospital
Brooklyn, New York, United States
Site Status
Research Foundation State University of New York at Buffalo
Buffalo, New York, United States
Site Status
Buffalo Heart Group, LLC
Buffalo, New York, United States
Site Status
Jamaica Hospital Medical Center
Jamaica, New York, United States
Site Status
Mid Valley Cardiology
Kingston, New York, United States
Site Status
Winthrop Cardiology Associates
Mineola, New York, United States
Site Status
Soundshore Medical Center of Westchester
New Rochelle, New York, United States
Site Status
NYU School of Medicine
New York, New York, United States
Site Status
St. Lukes Roosevelt
New York, New York, United States
Site Status
Northport VA Medical Center
Northport, New York, United States
Site Status
University of Rochester Medical Center
Rochester, New York, United States
Site Status
Lewin, Fagen, and Lown, MD, PC
Smithtown, New York, United States
Site Status
SUNY Upstate Medical Center
Syracuse, New York, United States
Site Status
Syracuse VA Medical Center
Syracuse, New York, United States
Site Status
Bronx-Lebanon Hospital Center
The Bronx, New York, United States
Site Status
Northeast Medical Center
Concord, North Carolina, United States
Site Status
Durham VA Medical Center
Durham, North Carolina, United States
Site Status
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Site Status
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
Site Status
University of Cincinnati
Cincinnati, Ohio, United States
Site Status
University Hospitals of Cleveland/Case Western Reserve University
Cleveland, Ohio, United States
Site Status
MetroHealth Medical Center
Cleveland, Ohio, United States
Site Status
Ohio State University Hospital East
Columbus, Ohio, United States
Site Status
VAMC Dayton
Dayton, Ohio, United States
Site Status
CCHS Clinical Research Office/Marymount Hospital
Garfield Heights, Ohio, United States
Site Status
CCHS Clinical Research Office/ Hillcrest Hospital
Mayfield Heights, Ohio, United States
Site Status
COR Clinical Research
Oklahoma City, Oklahoma, United States
Site Status
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States
Site Status
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States
Site Status
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Site Status
St. Charles Health System
Bend, Oregon, United States
Site Status
Providence Heart and Vascular Institute
Portland, Oregon, United States
Site Status
Capital Area Research
Camp Hill, Pennsylvania, United States
Site Status
Geisinger Medical Center
Danville, Pennsylvania, United States
Site Status
Medicor Associates, Inc
Erie, Pennsylvania, United States
Site Status
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Site Status
Lancaster Heart and Stroke Foundation
Lancaster, Pennsylvania, United States
Site Status
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Site Status
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
Thomas Jefferson University Hospital- Dept. of Family and Community Health
Philadelphia, Pennsylvania, United States
Site Status
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Site Status
Temple University Hospital
Philadelphia, Pennsylvania, United States
Site Status
Eastwick Primary Care
Philadelphia, Pennsylvania, United States
Site Status
Pittsburgh VA Healthcare System
Pittsburgh, Pennsylvania, United States
Site Status
The Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
Site Status
Memorial Hospital Rhode Island
Pawtucket, Rhode Island, United States
Site Status
VAMC - Charleston, SC
Charleston, South Carolina, United States
Site Status
Black Hills VA Health Care System
Fort Meade, South Dakota, United States
Site Status
The Stern Cardiovascular Center
Germantown, Tennessee, United States
Site Status
Memphis VA Medical Center
Memphis, Tennessee, United States
Site Status
Memphis Heart Clinic
Memphis, Tennessee, United States
Site Status
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Site Status
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States
Site Status
DCT - APHC, LLC dba Discovery Clinical Trials
Arlington, Texas, United States
Site Status
Dallas VA Medical Center
Dallas, Texas, United States
Site Status
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States
Site Status
U.T. Southwestern Medical Center
Dallas, Texas, United States
Site Status
Michael E. DeBakey VA Medical Cntr.
Houston, Texas, United States
Site Status
The Methodist Hospital Research Institute
Houston, Texas, United States
Site Status
Wilford Hall Medical Center
Lackland City, Texas, United States
Site Status
Texas Tech University Health Sciences Center
Odessa, Texas, United States
Site Status
Cardiology Clinic of San Antonio
San Antonio, Texas, United States
Site Status
Tyler Cardiovascular Consultants
Tyler, Texas, United States
Site Status
LDS Hospital
Murray, Utah, United States
Site Status
University of Utah
Salt Lake City, Utah, United States
Site Status
Cardiovascular Associates Ltd.
Chesapeake, Virginia, United States
Site Status
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Site Status
Evergreen Healthcare
Kirkland, Washington, United States
Site Status
Providence St. Peter Hospital
Olympia, Washington, United States
Site Status
Sound Health Research
Port Orchard, Washington, United States
Site Status
University of Washington
Seattle, Washington, United States
Site Status
CAMC Health Education and Research Institute
Charleston, West Virginia, United States
Site Status
William S. Middleton Memorial VA Hospital
Madison, Wisconsin, United States
Site Status
University of Wisconsin-Madison
Madison, Wisconsin, United States
Site Status
Aspirus Heart and Vascular Institute
Wausau, Wisconsin, United States
Site Status
Instituto de Investigaciones Clinicas de Bahia Blanca
BahÃa Blanca, Buenos Aires, Argentina
Site Status
IMAI Research
Buenos Aires, Buenos Aires, Argentina
Site Status
CIPREC
Buenos Aires, Buenos Aires, Argentina
Site Status
Instituto Cardiologico Ezpecializado S.R.L
Buenos Aires, Buenos Aires, Argentina
Site Status
Clinica IMA
Buenos Aires, Buenos Aires, Argentina
Site Status
Clinica Coronel Suarez
Coronel Suárez, Buenos Aires, Argentina
Site Status
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Site Status
Instituto de Investigaciones Clinicas de Mar Del Plata
Mar del Plata, Buenos Aires, Argentina
Site Status
Instituto de Investigaciones Clinicas de Quilmes
Quilmes, Buenos Aires, Argentina
Site Status
Clinica Privada Del Prado
Córdoba, Córdoba Province, Argentina
Site Status
Policlinico Modelo de Cipoletti
Cipolletti, RÃo Negro Province, Argentina
Site Status
Hospital San Bernardo
Salta, Salta Province, Argentina
Site Status
Centro de Investigaciones Clinicas del Litoral SRL
Santa Fe, Santa Fe Province, Argentina
Site Status
Centro Privado de Cardiologia
San Miguel de Tucumán, Tucumán Province, Argentina
Site Status
Instituto de Investigaciones Clinicas de Rosario
Rosario Santa Fe, , Argentina
Site Status
Centro Modelo de CardiologÃa
San Miguel de Tucumán, , Argentina
Site Status
Instituto de Cardiologia SRL
San Miguel de Tucumán, , Argentina
Site Status
Sanatorio Mayo S.A.
Santa Fe, , Argentina
Site Status
Hospital Felicio Rocho
Belo Horizonte, , Brazil
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Santa Casa De Belo Horizonte
Belo Horizonte, , Brazil
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HMCP PUC Campinas
Campinas, , Brazil
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Irmandade da Santa Casa de Misericordia de Curitiba
Curitiba Parana, , Brazil
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Hospital das Clinicas da Universidade Federal de Goias
Goiás, , Brazil
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Instituto do Coracao de Marilia
Marilia Sao Paulo, , Brazil
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Hospital Sao Vicente de Paulo
Passo Fundo, , Brazil
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PROCAPE
Pernambuco, , Brazil
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Hospital de Clinicas de Porto Alegre
Porto Alegre, , Brazil
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Hospital Mae De Deus
Porto Alegre, , Brazil
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Hospital Universitario Pedro Ernesto
Rio de Janeiro, , Brazil
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Santa Casa de Misericordia do Rio de Janeiro
Rio de Janeiro, , Brazil
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Instituto de Cardiologia de Santa Catarina
Santa Catarina, , Brazil
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Incor Fmusp
São Paulo, , Brazil
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Instituto de Molestias Cardiosvaculares
São Paulo, , Brazil
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UNIFESP/Hospital Sao Paulo
São Paulo, , Brazil
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Instituto do Coracao do Triangulo Mineiro
Uberlândia, , Brazil
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University of Calgary
Calgary, Alberta, Canada
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Fraser Clinical Trials Inc.
New Westminster, British Columbia, Canada
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St. Boniface General Hospital
Winnipeg, Manitoba, Canada
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Health Science Centre
St. John's, Newfoundland and Labrador, Canada
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Capital District Health Authority
Halifax, Nova Scotia, Canada
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Dr. Saul Vizel Cardiac Research Office
Cambridge, Ontario, Canada
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Cornwall Clinical Trials
Cornwall, Ontario, Canada
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Dr. Gurcharan Syan (PP)
Greater Sudbury, Ontario, Canada
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Hamilton Health Sciences - General Site
Hamilton, Ontario, Canada
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London Health Sciences Center
London, Ontario, Canada
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Ottawa Heart Institute
Ottawa, Ontario, Canada
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St. Michael's Hospital
Toronto, Ontario, Canada
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Mount Sinai Hospital
Toronto, Ontario, Canada
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CHUS - Hopital Fleurimont
Fleurimont, Quebec, Canada
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Service de la Recherche
Granby, Quebec, Canada
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Cite de la Sante de Laval
Laval, Quebec, Canada
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Clinique Cardiologie Levis
Lévis, Quebec, Canada
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Hopital Du Sacre Coeur de Montreal
Montreal, Quebec, Canada
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Montreal Heart Institute
Montreal, Quebec, Canada
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CHUM - Hotel Dieu
Montreal, Quebec, Canada
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Chum Hotel Dieu
Montreal, Quebec, Canada
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Royal Victoria Hospital
Montreal, Quebec, Canada
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Montreal General Hospital
Montreal, Quebec, Canada
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Centre de recherche clinique de Quebec
Québec, Quebec, Canada
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C.S.S.S.B.
Saint George, Quebec, Canada
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Centre Hosp Regional de Lanaudiere
Sainte Charles Borromee, Quebec, Canada
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Hopital Laval
Ste-Foy, Quebec, Canada
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CSSS du Sud de Lanaudiere (Hopital Pierre-Le Gardeur)
Terrebonne, Quebec, Canada
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Centre De Sante et De Services Sociaux De Thetford
Thetford-Mines, Quebec, Canada
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Misericordia Hospital - Cardiac Sciences
Edmonton, , Canada
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CDRC Rive-Sud
Longueuil, , Canada
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SMBD Jewish General Hospital
Montreal, , Canada
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Saskatchewan Heart Centre
Saskatoon, , Canada
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Cardiology Clinical Trials - Surrey Memorial Hospital
Surrey, , Canada
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Centre Hospitalier de Trois-Rivieres
Trois-Rivières, , Canada
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Cardio-Reanimation Centre
Tbilisi, K'alak'i T'bilisi, Georgia
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L &J Clinic
Kutaisi, , Georgia
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Tbilisi State Medical University Clinic #1
Tbilisi, , Georgia
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Cardiology Clinic
Tbilisi, , Georgia
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Multiprofile Clinical Hospital of Tbilisi #2
Tbilisi, , Georgia
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Emergency Cardiology Centre
Tbilisi, , Georgia
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National Center of Therapy
Tbilisi, , Georgia
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Diagnostic Services Clinic
Tbilisi, , Georgia
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Clinic of Angiocardiology "ADAPTI"
Tbilisi, , Georgia
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Kaliningrad Region Hospital
Kaliningrad, Kaliningrad Oblast, Russia
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Municipal Healthcare Institution <>
Gatchina, Leningradskaya Oblast', Russia
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Federal State Institution
Saratov, Saratov Oblast, Russia
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City Healthcare Institution Clinical Hospital #8
Yaroslavl, Yaroslavl Oblast, Russia
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Yaroslavl Regional Clinical Hospital
Yaroslavl, Yaroslavl Oblast, Russia
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Altay State Medical University of federal agency of public health and social progress RF
Barnaul, , Russia
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Municipal Health Care Institution "City Hospital #1"
Barnaul, , Russia
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Kemerovo Cadiologiy Dispensary, Kemerovo Medical Academy
Kemerovo, , Russia
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Nonstate Healthcare Institution
Kemerovo, , Russia
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State Healthcare Institution "Region Clinical Hospital #1
Krasnodar, , Russia
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National Research Center for Preventitive Medicine
Moscow, , Russia
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Russian State Medical University, Hospital Therapy Department #1
Moscow, , Russia
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State Education High Professional Education Russian State Medical University
Moscow, , Russia
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Federal State Institution "Outpatient clinic #3 of President's Management Department of Russian Fede
Moscow, , Russia
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Research Institute of Physico-Chemical Medicine Center for Atheosclerosis and Laboratory
Moscow, , Russia
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Non State Health Care Institution Central Hospital #6 of Russian Railways JSC
Moscow, , Russia
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Novosibirsk Municipal Clinical Emergency Hosp. # 2
Novosibirsk, , Russia
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Almasov research institute of Cardiology
Saint Petersberg, , Russia
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Public Institution of Health City Hospital # 28
Saint Petersburg, , Russia
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State Institution Saint-Petersburg Dzhanelidze Scientific
Saint Petersburg, , Russia
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Saint-Petersburg State Healthcare Institution "City Alexander's Hospital"
Saint Petersburg, , Russia
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Saint-Petersburg Clinical Hospital of RAMS, policlinic department
Saint Petersburg, , Russia
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Federal State Health Care Institution
Saint Petersburg, , Russia
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Saint-Petersburg State Health Care Institution "City Hospital of Saint George the Martyr"
Saint Petersburg, , Russia
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Non-state Health Care Institution
Saint Petersburg, , Russia
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City Hospital #26
Saint Petersburg, , Russia
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City Hospital No 26
Saint Petersburg, , Russia
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Chair and Department of Hospital Therapy
Saint Petersburg, , Russia
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Medico- Military Academy, Navy Therapy Dept
Saint Petersburg, , Russia
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Saint-Petersburg State Institution of Health Protection, "City Hosptial # 15"
Saint Petersburg, , Russia
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Saint-Petersburg State Health Institution "Pokrovskaya City Hospital"
Saint Petersburg, , Russia
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Chair of Nephrology and Dialysis of St Petersburg State Medical University
Saint Petersburg, , Russia
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State Educational Institution of High Professional Education Saratov State Medical University
Saratov, , Russia
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State Institition Research Institution of Cardiology of Tomsk
Tomsk, , Russia
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State Educational institution of Higher Professional Education "Volgograd State Medical University o
Volgograd, , Russia
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State Health Care Institution "Voronezh Regional Clinical Consultative & Diagnostic Centre"
Voronezh, , Russia
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References
Explore related publications, articles, or registry entries linked to this study.
Desai AS, Lewis EF, Li R, Solomon SD, Assmann SF, Boineau R, Clausell N, Diaz R, Fleg JL, Gordeev I, McKinlay S, O'Meara E, Shaburishvili T, Pitt B, Pfeffer MA. Rationale and design of the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial: a randomized, controlled study of spironolactone in patients with symptomatic heart failure and preserved ejection fraction. Am Heart J. 2011 Dec;162(6):966-972.e10. doi: 10.1016/j.ahj.2011.09.007. Epub 2011 Nov 8.
Reference Type
BACKGROUND
Shah SJ, Heitner JF, Sweitzer NK, Anand IS, Kim HY, Harty B, Boineau R, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Lewis EF, Markov V, O'Meara E, Kobulia B, Shaburishvili T, Solomon SD, Pitt B, Pfeffer MA, Li R. Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial. Circ Heart Fail. 2013 Mar;6(2):184-92. doi: 10.1161/CIRCHEARTFAILURE.112.972794. Epub 2012 Dec 20.
Reference Type
RESULT
Shah AM, Shah SJ, Anand IS, Sweitzer NK, O'Meara E, Heitner JF, Sopko G, Li G, Assmann SF, McKinlay SM, Pitt B, Pfeffer MA, Solomon SD; TOPCAT Investigators. Cardiac structure and function in heart failure with preserved ejection fraction: baseline findings from the echocardiographic study of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial. Circ Heart Fail. 2014 Jan;7(1):104-15. doi: 10.1161/CIRCHEARTFAILURE.113.000887. Epub 2013 Nov 18.
Reference Type
RESULT
Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.1056/NEJMoa1313731.
Reference Type
RESULT
Shah AM, Claggett B, Sweitzer NK, Shah SJ, Anand IS, O'Meara E, Desai AS, Heitner JF, Li G, Fang J, Rouleau J, Zile MR, Markov V, Ryabov V, Reis G, Assmann SF, McKinlay SM, Pitt B, Pfeffer MA, Solomon SD. Cardiac structure and function and prognosis in heart failure with preserved ejection fraction: findings from the echocardiographic study of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) Trial. Circ Heart Fail. 2014 Sep;7(5):740-51. doi: 10.1161/CIRCHEARTFAILURE.114.001583. Epub 2014 Aug 13.
Reference Type
RESULT
Pfeffer MA, Claggett B, Assmann SF, Boineau R, Anand IS, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Heitner JF, Lewis EF, O'Meara E, Rouleau JL, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, McKinlay SM, Pitt B. Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial. Circulation. 2015 Jan 6;131(1):34-42. doi: 10.1161/CIRCULATIONAHA.114.013255. Epub 2014 Nov 18.
Reference Type
RESULT
Tang Y, Li W, Wang Z, Chu SH, Wu Y, Jia Z, Hua C, Zhang H, Liu X, Lv Q, Jiang C, Dong JZ, Ma CS, Du X. Changes in frailty based on minimally important difference and the impact of spironolactone on frailty in heart failure with preserved ejection fraction: insights from the TOPCAT trial. Open Heart. 2025 Oct 22;12(2):e003487. doi: 10.1136/openhrt-2025-003487.
Reference Type
DERIVED
Ferreira JP, Mendonca L, Marques P, Neves JS, Zannad F, Packer M. Albuminuria Is the Key Driver of Kidney Benefit with Aldosterone Receptor Antagonists in Type 2 Diabetes. J Am Soc Nephrol. 2025 Sep 2. doi: 10.1681/ASN.0000000877. Online ahead of print. No abstract available.
Reference Type
DERIVED
Xu W, Xiao Z, Tang Y, Li Y, Chen X, He F, Huang H, Li C, Liu Y, Zhou J, Wang Y, Bin J, Chen Y. Association of serum potassium time in target range with cardiovascular outcomes in patients with HFpEF. Open Heart. 2025 Aug 21;12(2):e003439. doi: 10.1136/openhrt-2025-003439.
Reference Type
DERIVED
Inciardi RM, Vaduganathan M, Claggett B, AbouEzzeddine OF, Borlaug BA, Desai AS, Jhund PS, Lam CSP, Minamisawa M, Lewis EF, Redfield MM, Shah SJ, Fontana M, Pfeffer MA, McMurray JJV, Solomon SD. Application of a transthyretin amyloid cardiomyopathy score to heart failure with mildly reduced or preserved ejection fraction. Eur J Heart Fail. 2025 Jun 9. doi: 10.1002/ejhf.3698. Online ahead of print.
Reference Type
DERIVED
Xing F, Gao M, Wu Y, Liang W, Jiang J, Dong YG, Li Y, Dong B, Liu C. Influence of depression trajectories in heart failure patients with preserved ejection fractions: a secondary analysis of adverse outcomes in the TOPCAT trial. Heart. 2025 Jul 14;111(15):733-740. doi: 10.1136/heartjnl-2024-324505.
Reference Type
DERIVED
Xu W, He F, Huang H, Yang Z, Xiao Z, Zhou Y, Chen W, Zhou J, Lu P, Ma Y, Huang S, Liao Y, Bin J, Chen Y. A body shape index for visceral fat and its changes predict cardiovascular outcomes of heart failure with preserved ejection fraction. Eur Heart J Qual Care Clin Outcomes. 2025 Feb 28:qcaf005. doi: 10.1093/ehjqcco/qcaf005. Online ahead of print.
Reference Type
DERIVED
Fu Y, Feng S, Gu Z, Liu X, Zhu W, Wei B, Guo L. Associations of Depression, Antidepressants with Atrial Fibrillation Risk in HFpEF Patients. Rev Cardiovasc Med. 2024 Oct 22;25(10):370. doi: 10.31083/j.rcm2510370. eCollection 2024 Oct.
Reference Type
DERIVED
Zhang Q, Tai S, Zhou S. Abdominal obesity is associated with increased worsening renal function risk in patients with heart failure with preserved ejection fraction. BMC Cardiovasc Disord. 2024 Sep 9;24(1):477. doi: 10.1186/s12872-024-04118-0.
Reference Type
DERIVED
Desai RJ, Glynn RJ, Solomon SD, Claggett B, Wang SV, Vaduganathan M. Individualized Treatment Effect Prediction with Machine Learning - Salient Considerations. NEJM Evid. 2024 Apr;3(4):EVIDoa2300041. doi: 10.1056/EVIDoa2300041. Epub 2024 Mar 26.
Reference Type
DERIVED
Pfeffer MA, Claggett B. Behind the Scenes of TOPCAT - Bending to Inform. NEJM Evid. 2022 Jan;1(1):EVIDctcs2100007. doi: 10.1056/EVIDctcs2100007. Epub 2022 Jan 10.
Reference Type
DERIVED
Kondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.
Reference Type
DERIVED
Huang X, Liu X, Jiang Y, Cao Z, Wu M, Chen Z, Sun R, Yu P, Ma J, Zhu W, Chen Y, Wu G, Zhang Y, Wang J. Association of Body Mass Index and Abdominal Obesity with Incidence of Atrial Fibrillation in Heart Failure with Preserved Ejection Fraction. Curr Med Chem. 2025;32(16):3283-3294. doi: 10.2174/0929867330666230606100903.
Reference Type
DERIVED
Saksena S, Slee A, Natale A, Lakkireddy DR, Shah D, Di Biase L, Lewalter T, Nagarakanti R, Santangeli P. Atrial Fibrillation can adversely impact Heart Failure with Preserved Ejection Fraction by its association with Heart Failure Progression and Mortality: A Post-Hoc Propensity Score-Matched Analysis of the TOPCAT Americas Trial. Europace. 2023 May 19;25(5):euad095. doi: 10.1093/europace/euad095.
Reference Type
DERIVED
Cao Y, Guo S, Dong Y, Liu C, Zhu W. Comparison of liver fibrosis scores for predicting mortality and morbidity in heart failure with preserved ejection fraction. ESC Heart Fail. 2023 Jun;10(3):1771-1780. doi: 10.1002/ehf2.14336. Epub 2023 Mar 2.
Reference Type
DERIVED
Curtain JP, Adamson C, Kondo T, Butt JH, Desai AS, Zannad F, Rouleau JL, Rohde LE, Kober L, Anand IS, van Veldhuisen DJ, Zile MR, Lefkowitz MP, Solomon SD, Packer M, Petrie MC, Jhund PS, McMurray JJV. Investigator-reported ventricular arrhythmias and mortality in heart failure with mildly reduced or preserved ejection fraction. Eur Heart J. 2023 Feb 21;44(8):668-677. doi: 10.1093/eurheartj/ehac801.
Reference Type
DERIVED
Chen C, Zhao J, Xue R, Liu X, Zhu W, Ye M. Prognostic significance of resting cardiac power to left ventricular mass and E/e' ratio in heart failure with preserved ejection fraction. Front Cardiovasc Med. 2022 Aug 18;9:961837. doi: 10.3389/fcvm.2022.961837. eCollection 2022.
Reference Type
DERIVED
Zhu W, Cao Y, Ye M, Huang H, Wu Y, Ma J, Dong Y, Liu X, Liu C, Lip GYH. Essen Stroke Risk Score Predicts Clinical Outcomes in Heart Failure Patients with Preserved Ejection Fraction: Evidence from the TOPCAT trial. Thromb Haemost. 2023 Jan;123(1):85-96. doi: 10.1055/a-1932-8854. Epub 2022 Aug 29.
Reference Type
DERIVED
Zeng S, Cai X, Zheng Y, Liu X, Ye M. Associations of body mass index with mortality in heart failure with preserved ejection fraction patients with ischemic versus non-ischemic etiology. Front Cardiovasc Med. 2022 Aug 4;9:966745. doi: 10.3389/fcvm.2022.966745. eCollection 2022.
Reference Type
DERIVED
Vaduganathan M, Ferreira JP, Rossignol P, Neuen BL, Claggett BL, Pfeffer MA, McMurray JJV, Pitt B, Zannad F, Solomon SD. Effects of steroidal mineralocorticoid receptor antagonists on acute and chronic estimated glomerular filtration rate slopes in patients with chronic heart failure. Eur J Heart Fail. 2022 Sep;24(9):1586-1590. doi: 10.1002/ejhf.2635. Epub 2022 Aug 31.
Reference Type
DERIVED
Barkoudah E, Claggett BL, Lewis EF, O'Meara E, Clausell N, Diaz R, Fleg JL, Pitt B, Rouleau JL, Solomon SD, Pfeffer MA, Desai AS. Prognostic Impact of Cardiovascular Versus Noncardiovascular Hospitalizations in Heart Failure With Preserved Ejection Fraction: Insights From TOPCAT. J Card Fail. 2022 Sep;28(9):1390-1397. doi: 10.1016/j.cardfail.2022.05.004. Epub 2022 May 28.
Reference Type
DERIVED
Yang Y, Zhou Y, Cao Y, Dong Y, Liu C, Zhu W. Impact of diabetic retinopathy on prognosis of patients with heart failure with preserved ejection fraction. Nutr Metab Cardiovasc Dis. 2022 Jul;32(7):1711-1718. doi: 10.1016/j.numecd.2022.04.020. Epub 2022 Apr 27.
Reference Type
DERIVED
Vaduganathan M, Claggett BL, Inciardi RM, Fonarow GC, McMurray JJV, Solomon SD. Estimating the Benefits of Combination Medical Therapy in Heart Failure With Mildly Reduced and Preserved Ejection Fraction. Circulation. 2022 Jun 7;145(23):1741-1743. doi: 10.1161/CIRCULATIONAHA.121.058929. Epub 2022 May 23. No abstract available.
Reference Type
DERIVED
Ye M, Choy M, Liu X, Huang P, Wu Y, Dong Y, Zhu W, Liu C. Associations of BMI with mortality in HFpEF patients with concomitant diabetes with insulin versus non-insulin treatment. Diabetes Res Clin Pract. 2022 Mar;185:109805. doi: 10.1016/j.diabres.2022.109805. Epub 2022 Feb 24.
Reference Type
DERIVED
Guo L, Liu X, Yu P, Zhu W. The "Obesity Paradox" in Patients With HFpEF With or Without Comorbid Atrial Fibrillation. Front Cardiovasc Med. 2022 Jan 11;8:743327. doi: 10.3389/fcvm.2021.743327. eCollection 2021.
Reference Type
DERIVED
Sun J, Tai S, Guo Y, Tang L, Yang H, Li X, Xing Z, Fu L, Zhou S. Sex Differences in Characteristics and Outcomes in Elderly Heart Failure Patients With Preserved Ejection Fraction: A Post-hoc Analysis From TOPCAT. Front Cardiovasc Med. 2021 Oct 4;8:721850. doi: 10.3389/fcvm.2021.721850. eCollection 2021.
Reference Type
DERIVED
Hejjaji V, Tang Y, Coles T, Jones PG, Reeve BB, Mentz RJ, Spatz ES, Dunlay SM, Caldwell B, Saha A, Tarver ME, Tran A, Patel KK, Henke D, Pina IL, Spertus JA. Psychometric Evaluation of the Kansas City Cardiomyopathy Questionnaire in Men and Women With Heart Failure. Circ Heart Fail. 2021 Sep;14(9):e008284. doi: 10.1161/CIRCHEARTFAILURE.120.008284. Epub 2021 Sep 1.
Reference Type
DERIVED
Shin SH, Claggett B, Inciardi RM, Santos ABS, Shah SJ, Zile MR, Pfeffer MA, Shah AM, Solomon SD. Prognostic Value of Minimal Left Atrial Volume in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Aug 3;10(15):e019545. doi: 10.1161/JAHA.120.019545. Epub 2021 Jul 30.
Reference Type
DERIVED
Li Y, Yu Y, Wu Y, Liang W, Dong B, Xue R, Dong Y, Zhu W, Huang P. Association of Body-Weight Fluctuation With Outcomes in Heart Failure With Preserved Ejection Fraction. Front Cardiovasc Med. 2021 Jun 14;8:689591. doi: 10.3389/fcvm.2021.689591. eCollection 2021.
Reference Type
DERIVED
Huang P, Guo Z, Liang W, Wu Y, Zhao J, He X, Zhu W, Liu C, Dong Y, Yu Y, Dong B. Weight Change and Mortality Risk in Heart Failure With Preserved Ejection Fraction. Front Cardiovasc Med. 2021 Jun 4;8:681726. doi: 10.3389/fcvm.2021.681726. eCollection 2021.
Reference Type
DERIVED
Zhu W, Wu Y, Zhou Y, Liang W, Xue R, Wu Z, Wu D, He J, Dong Y, Liu C. Living Alone and Clinical Outcomes in Patients With Heart Failure With Preserved Ejection Fraction. Psychosom Med. 2021 Jun 1;83(5):470-476. doi: 10.1097/PSY.0000000000000945.
Reference Type
DERIVED
Lin Y, Zhong X, Liu M, Zhang S, Xiong Z, Huang Y, Fan Y, Xu X, Guo Y, Li Y, Sun X, Zhou H, Yang D, Ye X, Liao X, Zhuang X. Risk Stratification and Efficacy of Spironolactone in Patients with Heart Failure with Preserved Ejection Fraction: Secondary Analysis of the TOPCAT Randomized Clinical Trial. Cardiovasc Drugs Ther. 2022 Apr;36(2):323-331. doi: 10.1007/s10557-021-07178-y. Epub 2021 Apr 1.
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DERIVED
De Marco C, Claggett BL, de Denus S, Zile MR, Huynh T, Desai AS, Sirois MG, Solomon SD, Pitt B, Rouleau JL, Pfeffer MA, O'Meara E. Impact of diabetes on serum biomarkers in heart failure with preserved ejection fraction: insights from the TOPCAT trial. ESC Heart Fail. 2021 Apr;8(2):1130-1138. doi: 10.1002/ehf2.13153. Epub 2021 Jan 12.
Reference Type
DERIVED
Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10.
Reference Type
DERIVED
Wu Y, Zhu W, He X, Xue R, Liang W, Wei F, Wu Z, Zhou Y, Wu D, He J, Dong Y, Liu C. Influence of polypharmacy on patients with heart failure with preserved ejection fraction: a retrospective analysis on adverse outcomes in the TOPCAT trial. Br J Gen Pract. 2020 Dec 28;71(702):e62-e70. doi: 10.3399/bjgp21X714245. Print 2021 Jan.
Reference Type
DERIVED
Yang S, Troendle J. Event-specific win ratios and testing with terminal and non-terminal events. Clin Trials. 2021 Apr;18(2):180-187. doi: 10.1177/1740774520972408. Epub 2020 Nov 24.
Reference Type
DERIVED
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
Reference Type
DERIVED
Zhu W, Liang W, Ye Z, Wu Y, He X, Xue R, Wu Z, Zhou Y, Zhao J, Dong Y, Liu C. Association of physical activity and risk of atrial fibrillation in heart failure with preserved ejection fraction. Nutr Metab Cardiovasc Dis. 2021 Jan 4;31(1):247-253. doi: 10.1016/j.numecd.2020.08.022. Epub 2020 Aug 23.
Reference Type
DERIVED
Chandra A, Alcala MAD, Claggett B, Desai AS, Fang JC, Heitner JF, Liu J, Pitt B, Solomon SD, Pfeffer MA, Lewis EF. Associations Between Depressive Symptoms and HFpEF-Related Outcomes. JACC Heart Fail. 2020 Dec;8(12):1009-1020. doi: 10.1016/j.jchf.2020.06.010. Epub 2020 Sep 9.
Reference Type
DERIVED
Zhu W, Wu Y, Zhou Y, Liang W, Xue R, Wu Z, Dong Y, Liu C. CHA2DS2-VASc and ATRIA Scores and Clinical Outcomes in Patients with Heart Failure with Preserved Ejection Fraction. Cardiovasc Drugs Ther. 2020 Dec;34(6):763-772. doi: 10.1007/s10557-020-07011-y.
Reference Type
DERIVED
Cunningham JW, Vaduganathan M, Claggett BL, John JE, Desai AS, Lewis EF, Zile MR, Carson P, Jhund PS, Kober L, Pitt B, Shah SJ, Swedberg K, Anand IS, Yusuf S, McMurray JJV, Pfeffer MA, Solomon SD. Myocardial Infarction in Heart Failure With Preserved Ejection Fraction: Pooled Analysis of 3 Clinical Trials. JACC Heart Fail. 2020 Aug;8(8):618-626. doi: 10.1016/j.jchf.2020.02.007. Epub 2020 May 6.
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DERIVED
Flint KM, Shah SJ, Lewis EF, Kao DP. Variation in clinical and patient-reported outcomes among complex heart failure with preserved ejection fraction phenotypes. ESC Heart Fail. 2020 Jun;7(3):811-824. doi: 10.1002/ehf2.12660. Epub 2020 Mar 11.
Reference Type
DERIVED
Myhre PL, Vaduganathan M, O'Meara E, Claggett BL, de Denus S, Jarolim P, Anand IS, Pitt B, Rouleau JL, Solomon SD, Pfeffer MA, Desai AS. Mechanistic Effects of Spironolactone on Cardiovascular and Renal Biomarkers in Heart Failure With Preserved Ejection Fraction: A TOPCAT Biorepository Study. Circ Heart Fail. 2020 Jan;13(1):e006638. doi: 10.1161/CIRCHEARTFAILURE.119.006638. Epub 2020 Jan 20.
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Vardeny O, Claggett B, Vaduganathan M, Beldhuis I, Rouleau J, O'Meara E, Anand IS, Shah SJ, Sweitzer NK, Fang JC, Desai AS, Lewis EF, Pitt B, Pfeffer MA, Solomon SD; TOPCAT Investigators. Influence of Age on Efficacy and Safety of Spironolactone in Heart Failure. JACC Heart Fail. 2019 Dec;7(12):1022-1028. doi: 10.1016/j.jchf.2019.08.019.
Reference Type
DERIVED
Angraal S, Mortazavi BJ, Gupta A, Khera R, Ahmad T, Desai NR, Jacoby DL, Masoudi FA, Spertus JA, Krumholz HM. Machine Learning Prediction of Mortality and Hospitalization in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2020 Jan;8(1):12-21. doi: 10.1016/j.jchf.2019.06.013. Epub 2019 Oct 9.
Reference Type
DERIVED
Tromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052.
Reference Type
DERIVED
Beale AL, Nanayakkara S, Kaye DM. Impact of Sex on Ventricular-Vascular Stiffness and Long-Term Outcomes in Heart Failure With Preserved Ejection Fraction: TOPCAT Trial Substudy. J Am Heart Assoc. 2019 Jul 2;8(13):e012190. doi: 10.1161/JAHA.119.012190. Epub 2019 Jun 22.
Reference Type
DERIVED
Selvaraj S, Claggett B, Shah SJ, Anand IS, Rouleau JL, Desai AS, Lewis EF, Vaduganathan M, Wang SY, Pitt B, Sweitzer NK, Pfeffer MA, Solomon SD. Utility of the Cardiovascular Physical Examination and Impact of Spironolactone in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Jul;12(7):e006125. doi: 10.1161/CIRCHEARTFAILURE.119.006125. Epub 2019 Jun 21.
Reference Type
DERIVED
Neefs J, van den Berg NWE, Krul SPJ, Boekholdt SM, de Groot JR. Effect of Spironolactone on Atrial Fibrillation in Patients with Heart Failure with Preserved Ejection Fraction: Post-Hoc Analysis of the Randomized, Placebo-Controlled TOPCAT Trial. Am J Cardiovasc Drugs. 2020 Feb;20(1):73-80. doi: 10.1007/s40256-019-00353-5.
Reference Type
DERIVED
Kristensen SL, Mogensen UM, Jhund PS, Rorth R, Anand IS, Carson PE, Desai AS, Pitt B, Pfeffer MA, Solomon SD, Zile MR, Kober L, McMurray JJV. N-Terminal Pro-B-Type Natriuretic Peptide Levels for Risk Prediction in Patients With Heart Failure and Preserved Ejection Fraction According to Atrial Fibrillation Status. Circ Heart Fail. 2019 Mar;12(3):e005766. doi: 10.1161/CIRCHEARTFAILURE.118.005766.
Reference Type
DERIVED
Merrill M, Sweitzer NK, Lindenfeld J, Kao DP. Sex Differences in Outcomes and Responses to Spironolactone in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of TOPCAT Trial. JACC Heart Fail. 2019 Mar;7(3):228-238. doi: 10.1016/j.jchf.2019.01.003.
Reference Type
DERIVED
Myhre PL, O'Meara E, Claggett BL, de Denus S, Jarolim P, Anand IS, Beldhuis IE, Fleg JL, Lewis E, Pitt B, Rouleau JL, Solomon SD, Pfeffer MA, Desai AS. Cardiac Troponin I and Risk of Cardiac Events in Patients With Heart Failure and Preserved Ejection Fraction. Circ Heart Fail. 2018 Nov;11(11):e005312. doi: 10.1161/CIRCHEARTFAILURE.118.005312.
Reference Type
DERIVED
Selvaraj S, Claggett B, Shah SJ, Anand I, Rouleau JL, O'Meara E, Desai AS, Lewis EF, Pitt B, Sweitzer NK, Fang JC, Pfeffer MA, Solomon SD. Prognostic Value of Albuminuria and Influence of Spironolactone in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Nov;11(11):e005288. doi: 10.1161/CIRCHEARTFAILURE.118.005288.
Reference Type
DERIVED
Myhre PL, Vaduganathan M, Claggett BL, Anand IS, Sweitzer NK, Fang JC, O'Meara E, Shah SJ, Desai AS, Lewis EF, Rouleau J, Pitt B, Pfeffer MA, Solomon SD. Association of Natriuretic Peptides With Cardiovascular Prognosis in Heart Failure With Preserved Ejection Fraction: Secondary Analysis of the TOPCAT Randomized Clinical Trial. JAMA Cardiol. 2018 Oct 1;3(10):1000-1005. doi: 10.1001/jamacardio.2018.2568.
Reference Type
DERIVED
Cikes M, Claggett B, Shah AM, Desai AS, Lewis EF, Shah SJ, Anand IS, O'Meara E, Rouleau JL, Sweitzer NK, Fang JC, Saksena S, Pitt B, Pfeffer MA, Solomon SD. Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: The TOPCAT Trial. JACC Heart Fail. 2018 Aug;6(8):689-697. doi: 10.1016/j.jchf.2018.05.005. Epub 2018 Jul 11.
Reference Type
DERIVED
Lewis EF, Claggett B, Shah AM, Liu J, Shah SJ, Anand I, O'Meara E, Sweitzer NK, Rouleau JL, Fang JC, Desai AS, Retta TM, Solomon SD, Heitner JF, Stamos TD, Boineau R, Pitt B, Pfeffer MA. Racial Differences in Characteristics and Outcomes of Patients With Heart Failure and Preserved Ejection Fraction in the Treatment of Preserved Cardiac Function Heart Failure Trial. Circ Heart Fail. 2018 Mar;11(3):e004457. doi: 10.1161/CIRCHEARTFAILURE.117.004457.
Reference Type
DERIVED
Vaduganathan M, Claggett BL, Chatterjee NA, Anand IS, Sweitzer NK, Fang JC, O'Meara E, Shah SJ, Hegde SM, Desai AS, Lewis EF, Rouleau J, Pitt B, Pfeffer MA, Solomon SD. Sudden Death in Heart Failure With Preserved Ejection Fraction: A Competing Risks Analysis From the TOPCAT Trial. JACC Heart Fail. 2018 Aug;6(8):653-661. doi: 10.1016/j.jchf.2018.02.014. Epub 2018 Mar 4.
Reference Type
DERIVED
Rossignol P, Claggett BL, Liu J, Vardeny O, Pitt B, Zannad F, Solomon S. Spironolactone and Resistant Hypertension in Heart Failure With Preserved Ejection Fraction. Am J Hypertens. 2018 Mar 10;31(4):407-414. doi: 10.1093/ajh/hpx210.
Reference Type
DERIVED
Selvaraj S, Claggett B, Shah SJ, Anand I, Rouleau JL, Desai AS, Lewis EF, Pitt B, Sweitzer NK, Pfeffer MA, Solomon SD. Systolic blood pressure and cardiovascular outcomes in heart failure with preserved ejection fraction: an analysis of the TOPCAT trial. Eur J Heart Fail. 2018 Mar;20(3):483-490. doi: 10.1002/ejhf.1060. Epub 2017 Nov 16.
Reference Type
DERIVED
Pokharel Y, Khariton Y, Tang Y, Nassif ME, Chan PS, Arnold SV, Jones PG, Spertus JA. Association of Serial Kansas City Cardiomyopathy Questionnaire Assessments With Death and Hospitalization in Patients With Heart Failure With Preserved and Reduced Ejection Fraction: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Cardiol. 2017 Dec 1;2(12):1315-1321. doi: 10.1001/jamacardio.2017.3983.
Reference Type
DERIVED
Hegde SM, Claggett B, Shah AM, Lewis EF, Anand I, Shah SJ, Sweitzer NK, Fang JC, Pitt B, Pfeffer MA, Solomon SD. Physical Activity and Prognosis in the TOPCAT Trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist). Circulation. 2017 Sep 12;136(11):982-992. doi: 10.1161/CIRCULATIONAHA.117.028002. Epub 2017 Jun 21.
Reference Type
DERIVED
Anand IS, Claggett B, Liu J, Shah AM, Rector TS, Shah SJ, Desai AS, O'Meara E, Fleg JL, Pfeffer MA, Pitt B, Solomon SD. Interaction Between Spironolactone and Natriuretic Peptides in Patients With Heart Failure and Preserved Ejection Fraction: From the TOPCAT Trial. JACC Heart Fail. 2017 Apr;5(4):241-252. doi: 10.1016/j.jchf.2016.11.015.
Reference Type
DERIVED
Biering-Sorensen T, Shah SJ, Anand I, Sweitzer N, Claggett B, Liu L, Pitt B, Pfeffer MA, Solomon SD, Shah AM. Prognostic importance of left ventricular mechanical dyssynchrony in heart failure with preserved ejection fraction. Eur J Heart Fail. 2017 Aug;19(8):1043-1052. doi: 10.1002/ejhf.789. Epub 2017 Mar 21.
Reference Type
DERIVED
Santos AB, Roca GQ, Claggett B, Sweitzer NK, Shah SJ, Anand IS, Fang JC, Zile MR, Pitt B, Solomon SD, Shah AM. Prognostic Relevance of Left Atrial Dysfunction in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Apr;9(4):e002763. doi: 10.1161/CIRCHEARTFAILURE.115.002763.
Reference Type
DERIVED
Joseph J, Claggett BC, Anand IS, Fleg JL, Huynh T, Desai AS, Solomon SD, O'Meara E, Mckinlay S, Pitt B, Pfeffer MA, Lewis EF. QRS Duration Is a Predictor of Adverse Outcomes in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2016 Jun;4(6):477-86. doi: 10.1016/j.jchf.2016.02.013. Epub 2016 Mar 30.
Reference Type
DERIVED
Lewis EF, Kim HY, Claggett B, Spertus J, Heitner JF, Assmann SF, Kenwood CT, Solomon SD, Desai AS, Fang JC, McKinlay SA, Pitt BA, Pfeffer MA; TOPCAT Investigators. Impact of Spironolactone on Longitudinal Changes in Health-Related Quality of Life in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial. Circ Heart Fail. 2016 Mar;9(3):e001937. doi: 10.1161/CIRCHEARTFAILURE.114.001937.
Reference Type
DERIVED
Shah AM, Claggett B, Sweitzer NK, Shah SJ, Deswal A, Anand IS, Fleg JL, Pitt B, Pfeffer MA, Solomon SD. Prognostic Importance of Changes in Cardiac Structure and Function in Heart Failure With Preserved Ejection Fraction and the Impact of Spironolactone. Circ Heart Fail. 2015 Nov;8(6):1052-8. doi: 10.1161/CIRCHEARTFAILURE.115.002249. Epub 2015 Oct 16.
Reference Type
DERIVED
Solomon SD, Claggett B, Lewis EF, Desai A, Anand I, Sweitzer NK, O'Meara E, Shah SJ, McKinlay S, Fleg JL, Sopko G, Pitt B, Pfeffer MA; TOPCAT Investigators. Influence of ejection fraction on outcomes and efficacy of spironolactone in patients with heart failure with preserved ejection fraction. Eur Heart J. 2016 Feb 1;37(5):455-62. doi: 10.1093/eurheartj/ehv464. Epub 2015 Sep 15.
Reference Type
DERIVED
Shah AM, Claggett B, Sweitzer NK, Shah SJ, Anand IS, Liu L, Pitt B, Pfeffer MA, Solomon SD. Prognostic Importance of Impaired Systolic Function in Heart Failure With Preserved Ejection Fraction and the Impact of Spironolactone. Circulation. 2015 Aug 4;132(5):402-14. doi: 10.1161/CIRCULATIONAHA.115.015884. Epub 2015 Jun 30.
Reference Type
DERIVED
Borlaug BA, Lewis GD, McNulty SE, Semigran MJ, LeWinter M, Chen H, Lin G, Deswal A, Margulies KB, Redfield MM. Effects of sildenafil on ventricular and vascular function in heart failure with preserved ejection fraction. Circ Heart Fail. 2015 May;8(3):533-41. doi: 10.1161/CIRCHEARTFAILURE.114.001915. Epub 2015 Mar 17.
Reference Type
DERIVED
Hamo CE, Heitner JF, Pfeffer MA, Kim HY, Kenwood CT, Assmann SF, Solomon SD, Boineau R, Fleg JL, Spertus JA, Lewis EF. Baseline distribution of participants with depression and impaired quality of life in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial. Circ Heart Fail. 2015 Mar;8(2):268-77. doi: 10.1161/CIRCHEARTFAILURE.114.001838. Epub 2015 Feb 3.
Reference Type
DERIVED
Mak GJ, Ledwidge MT, Watson CJ, Phelan DM, Dawkins IR, Murphy NF, Patle AK, Baugh JA, McDonald KM. Natural history of markers of collagen turnover in patients with early diastolic dysfunction and impact of eplerenone. J Am Coll Cardiol. 2009 Oct 27;54(18):1674-82. doi: 10.1016/j.jacc.2009.08.021.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://circheartfailure.ahajournals.org/content/6/2/184.long
Link to PubMed ID #23258572 publication in Circulation: Heart Failure
http://circheartfailure.ahajournals.org/content/7/1/104.long
Link to PubMed ID #24249049 publication in Circulation: Heart Failure
http://www.nejm.org/doi/full/10.1056/NEJMoa1313731
Link to PubMed ID #24716680 publication in the New England Journal of Medicine
http://circheartfailure.ahajournals.org/content/7/5/740.long
Link to PubMed ID #25122186 publication in Circulation: Heart Failure
http://circ.ahajournals.org/content/early/2014/11/18/CIRCULATIONAHA.114.013255.long
Link to PubMed ID #25406305 publication in Circulation
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HHSN268200425207C
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
160
Identifier Type: -
Identifier Source: org_study_id
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