Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure
NCT ID: NCT01910389
Last Updated: 2015-05-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
23 participants
INTERVENTIONAL
2013-11-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tadalafil
Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
Tadalafil
Placebo
Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
Placebo for tadalafil
Interventions
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Tadalafil
Placebo for tadalafil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NYHA Class II-IV HF with LVSD (most recent LVEF \< 0.40).
* At high risk of future clinical instability, indicated by EITHER:
a hospitalization for the primary reason of decompensated HF within the 12 months prior to screening; OR a plasma B-type Natriuretic Peptide (BNP) level ≥ 300 pg/ml or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥1800pg/ml measured during a period of clinical stability in the 3 months prior to screening.
* Documented secondary PH within the last 6 months
* Medication and device treatment according to current American Heart Association/American College of Cardiology (AHA/ACC) guidelines.
* Stable medical therapy for 30 days prior to randomization
* African-American patients intolerant of or otherwise unable or unwilling to utilize isosorbide dinitrate/hydralazine therapy will be included.
* Willingness to comply with protocol, attend follow-up appointments, complete all study assessments and provide written informed consent.
Exclusion Criteria
* Known allergy, hypersensitivity (anaphylaxis), or adverse reaction to tadalafil or other Phosphodiesterase Type 5 (PDE5) inhibitor
* Erectile dysfunction treated with a PDE5 inhibitor.
* Severe renal dysfunction defined as an estimated glomerular filtration rate (GFR) \< 30 ml/min/1.73 m\^2 or requiring chronic dialysis
* Current use of alpha antagonists (except carvedilol or tamsulosin) or use of cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, erythromycin, or cimetidine). Patients who have used a protease inhibitor that is a P450 3A4 inhibitor for longer than one week can be enrolled.
* Pulmonary arterial hypertension (World Health Organization (WHO) Group I, III-V) for which PDE5 inhibitor therapy may be indicated
* Severe pulmonary disease requiring home oxygen therapy
* Comorbidities including clinically significant valvular stenosis (aortic valve area \< 0.8 cm\^2 or a mitral valve area \<1.0 cm\^2), uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg) or hypotension (systolic blood pressure \<85 mmHg)
* Chronic intravenous inotrope therapy
* Non-arteritic anterior ischemic optic neuropathy (NAION)
* ST elevation MI (STEMI) within 90 days prior to screening
* Coronary Artery Bypass Grafting (CABG) or mitral valve surgery, initiation of cardiac resynchronization (CRT) or initiation of β-blocker therapy within the 6 months prior to screening
* Infiltrative or inflammatory myocardial disease (e.g. amyloid, sarcoid)
* Heart transplant recipient
* United Network Organ Sharing (UNOS) status 1A or 1B
* Mechanical circulatory support (MCS) use or planned MCS use at time of consent
* Active malignancy (except non-melanoma skin cancer) requiring therapy other than observation.
* Severe non-cardiac illness resulting in life expectancy judged less than three years
* Known chronic hepatic disease defined as aspartate aminotransferase (AST) and alanine transaminase (ALT) levels \> 3.0 times the upper limit of normal
* Inability to walk even a few steps due to non-cardiac (e.g. orthopedic) reasons
* Participation in any clinical trial within the last 30 days (with exception of observational study)
* Previous randomization in PITCH-HF
21 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Massachusetts General Hospital
OTHER
Carelon Research
OTHER
Responsible Party
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Principal Investigators
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Marc J. Semigran, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Susan F Assmann, PhD
Role: PRINCIPAL_INVESTIGATOR
New England Research Institutes, Inc.
Flora S Siami, MPH
Role: PRINCIPAL_INVESTIGATOR
New England Research Institutes, Inc.
Locations
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Heart Center Inc - Research
Huntsville, Alabama, United States
Baptist Health Transplant Institute
Little Rock, Arkansas, United States
Allianz Medical and Research Center
Fountain Valley, California, United States
Christiana Care Health System
Newark, Delaware, United States
Broward Health
Fort Lauderdale, Florida, United States
Miller School of Medicine University of Miami
Miami, Florida, United States
Orlando Health
Orlando, Florida, United States
Charlotte Heart Group Research Center
Port Charlotte, Florida, United States
Brevard Cardiovascular Research Associates
Rockledge, Florida, United States
University Cardiology Associates LLC
Augusta, Georgia, United States
Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois Hospital
Chicago, Illinois, United States
Methodist Medical Group Cardiology
Peoria, Illinois, United States
Baptist Hospital East
Louisville, Kentucky, United States
Research Integrity LLC
Owensboro, Kentucky, United States
LSU Health Sciences Center
New Orleans, Louisiana, United States
Maine Research Associates
Auburn, Maine, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Primary Care Cardiology Research, Inc.
Ayer, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MGH West
Waltham, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Covenant Center for the Heart
Saginaw, Michigan, United States
Essentia Health East
Duluth, Minnesota, United States
Metropolitan Heart and Vascular Institute
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Missouri Cardiovascular Specialists
Columbia, Missouri, United States
St. Luke's Health System
Kansas City, Missouri, United States
Glacier View Research Institute
Kalispell, Montana, United States
Advanced Heart Care, LLC
Bridgewater, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Heart & Vascular Center of NJ/Cardio Metabolic Institute
Somerset, New Jersey, United States
New York Methodist Hospital
Brooklyn, New York, United States
Columbia University Medical Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Cardiology Associates of Schenectady
Schenectady, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Bronx - Lebanon Hospital Center
The Bronx, New York, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Dayton VA Medical Center
Dayton, Ohio, United States
Oklahoma City VA
Oklahoma City, Oklahoma, United States
Warren Cancer Research Foundation
Tulsa, Oklahoma, United States
Lancaster Heart and Stroke Foundation
Lancaster, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Grand View - Lehigh Valley Health Service
Sellersville, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, United States
CIVA/CArdiovascular Research Institute of Dallas
Dallas, Texas, United States
Michael E. Debakey VA Medical Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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