A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
NCT ID: NCT03254485
Last Updated: 2022-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
196 participants
INTERVENTIONAL
2017-11-07
2019-08-19
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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IW-1973 High Dose
IW-1973
Oral Tablet
Placebo
Placebo to match experimental drug
Placebo Oral Tablet
Oral Tablet
Interventions
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IW-1973
Oral Tablet
Placebo Oral Tablet
Oral Tablet
Eligibility Criteria
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Inclusion Criteria
2. Patient has heart failure with ejection fraction (EF) of ≥40%
3. Patient has a peak VO2 measuring \<80% of age- and sex-adjusted normal values
4. Patient has evidence in medical history supporting clinical heart failure syndrome consisting of at least 1 of the following:
1. Hospitalization or emergency department visit for heart failure within the past year
2. Elevated B-type natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) within the past 6 months
3. Echocardiographic evidence within the past 12 months of at least 2 of the following: left ventricular (LV) hypertrophy, left atrial (LA) enlargement, or diastolic dysfunction
4. Hemodynamic evidence of elevated filling pressures
5. Patient meets at least 2 of the following criteria at the Screening Visit:
1. Diagnosis of type 2 diabetes mellitus or prediabetes
2. History of hypertension
3. Body mass index (BMI) \>30 kg/m2
4. Age ≥70 years
Exclusion Criteria
2. Patient has had cardiac transplantation or has cardiac transplantation planned during the study
3. Patient has had cardiac artery bypass graft, cardiac mechanical support implantation, or other cardiac surgery in the 3 months before the Screening Visit or planned during the study
4. Patient has severe chronic obstructive coronary disease as defined by chronic oxygen dependence
5. Patient had had heart failure hospitalization with discharge within 30 days before the Screening Visit
6. Patient has a history of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products
7. Patient has previously received IW-1973 in a study, or received an investigational drug during the 30 days or 5 half lives of that investigational drug (whichever is longer) before the Screening Visit, or is planning to receive another investigational drug at any time during the study
8. Patient is taking specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors of PDE5, any supplements for the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide (NO) donors in any form
9. Patient is taking strong cytochrome P450 3A (CYP3A) inhibitors
10. Women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the Screening Visit through 60 days after the final dose of study drug
11. Male patients must be surgically sterile by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception from the Screening Visit through 60 days after the final dose of study drug
45 Years
ALL
No
Sponsors
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Cyclerion Therapeutics
INDUSTRY
Akebia Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Jelena Seferovic, MD PhD
Role: STUDY_DIRECTOR
Cyclerion Therapeutics, Inc.
Locations
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Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Cardiology and Medicine Clinic
Little Rock, Arkansas, United States
JEHM
La Mesa, California, United States
Axis Clinical Trials
Los Angeles, California, United States
JEHM
National City, California, United States
Valley Clinical Trials
Northridge, California, United States
Stanford University
Palo Alto, California, United States
Harbor UCLA Medical Center
Torrance, California, United States
Aurora Denver Cardiology
Denver, Colorado, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
New Generation of Medical Research
Hialeah, Florida, United States
East Coast Institute for Research
Jacksonville, Florida, United States
PCRS Network, LLC
Miami, Florida, United States
Broward Research Center
Pembroke Pines, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
St. Luke's Regional Medical Center
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Unity Point Health - Methodist Hospital
Peoria, Illinois, United States
Franciscan Physician Network - Indiana Heart Physicians
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Lousiana Heart Center
Bogalusa, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
Michigan Heart
Ypsilanti, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
VA Healthcare John Cochran Medical Center
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University Medical Center (OSUMC)
Columbus, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States
Newton Clinical Research
Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
PeaceHealth, Sacred Heart Physicians
Springfield, Oregon, United States
Research Institute of Lancaster General Health
Lancaster, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
North Dallas Research Associates
Dallas, Texas, United States
Texas Health Research and Education Insitute
Dallas, Texas, United States
Southwest Family Medicine Associates
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Schnitzler Cardiovascular Consultants
San Antonio, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Virginia Commonwealth University Medical College of Virginia
Richmond, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Unity Point Health
Madison, Wisconsin, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
London Health Sciences Centre
London, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec, , Canada
Countries
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References
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Udelson JE, Lewis GD, Shah SJ, Zile MR, Redfield MM, Burnett J Jr, Parker J, Seferovic JP, Wilson P, Mittleman RS, Profy AT, Konstam MA. Effect of Praliciguat on Peak Rate of Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: The CAPACITY HFpEF Randomized Clinical Trial. JAMA. 2020 Oct 20;324(15):1522-1531. doi: 10.1001/jama.2020.16641.
Udelson JE, Lewis GD, Shah SJ, Zile MR, Redfield MM, Burnett J Jr, Mittleman RS, Profy AT, Seferovic JP, Reasner D, Konstam MA. Rationale and design for a multicenter, randomized, double-blind, placebo-controlled, phase 2 study evaluating the safety and efficacy of the soluble guanylate cyclase stimulator praliciguat over 12 weeks in patients with heart failure with preserved ejection fraction (CAPACITY HFpEF). Am Heart J. 2020 Apr;222:183-190. doi: 10.1016/j.ahj.2020.01.009. Epub 2020 Jan 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C1973-204
Identifier Type: -
Identifier Source: org_study_id
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