Heart Failure Clinical Trial

A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

Summary

The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient is an ambulatory male or female ≥45 years old at the Screening Visit
Patient has heart failure with ejection fraction (EF) of ≥40%
Patient has a peak VO2 measuring <80% of age- and sex-adjusted normal values

Patient has evidence in medical history supporting clinical heart failure syndrome consisting of at least 1 of the following:

Hospitalization or emergency department visit for heart failure within the past year
Elevated B-type natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) within the past 6 months
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
Hemodynamic evidence of elevated filling pressures

Patient meets at least 2 of the following criteria at the Screening Visit:

Diagnosis of type 2 diabetes mellitus or prediabetes
History of hypertension
Body mass index (BMI) >30 kg/m2
Age ≥70 years

Exclusion Criteria:

Patient has had acute coronary syndrome or percutaneous coronary intervention within 30 days before Randomization
Patient has had cardiac transplantation or has cardiac transplantation planned during the study
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
Patient has severe chronic obstructive coronary disease as defined by chronic oxygen dependence
Patient had had heart failure hospitalization with discharge within 30 days before the Screening Visit
Patient has a history of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products
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
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
Patient is taking strong cytochrome P450 3A (CYP3A) inhibitors
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
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
Other exclusion criteria per protocol

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

196

Study ID:

NCT03254485

Recruitment Status:

Completed

Sponsor:

Akebia Therapeutics

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There are 62 Locations for this study

See Locations Near You

Arizona Arrhythmia Research Center
Phoenix Arizona, 85016, United States
Mayo Clinic
Scottsdale Arizona, 85259, United States
University of Arizona
Tucson Arizona, 85724, United States
Cardiology and Medicine Clinic
Little Rock Arkansas, 72204, United States
JEHM
La Mesa California, 91941, United States
Axis Clinical Trials
Los Angeles California, 90036, United States
JEHM
National City California, 91950, United States
Valley Clinical Trials
Northridge California, 91325, United States
Stanford University
Palo Alto California, 94305, United States
Harbor UCLA Medical Center
Torrance California, 90509, United States
Aurora Denver Cardiology
Denver Colorado, 80218, United States
South Denver Cardiology Associates
Littleton Colorado, 80120, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
New Generation of Medical Research
Hialeah Florida, 33016, United States
East Coast Institute for Research
Jacksonville Florida, 32216, United States
PCRS Network, LLC
Miami Florida, 33126, United States
Broward Research Center
Pembroke Pines Florida, 33024, United States
Progressive Medical Research
Port Orange Florida, 32127, United States
St. Luke's Regional Medical Center
Boise Idaho, 83712, United States
Northwestern University
Chicago Illinois, 60611, United States
Unity Point Health - Methodist Hospital
Peoria Illinois, 61602, United States
Franciscan Physician Network - Indiana Heart Physicians
Indianapolis Indiana, 46237, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Lousiana Heart Center
Bogalusa Louisiana, 70427, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Boston University School of Medicine
Boston Massachusetts, 02118, United States
Lahey Clinic
Burlington Massachusetts, 01805, United States
Michigan Heart
Ypsilanti Michigan, 48197, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
VA Healthcare John Cochran Medical Center
Saint Louis Missouri, 63106, United States
Washington University
Saint Louis Missouri, 63110, United States
The Valley Hospital
Ridgewood New Jersey, 07450, United States
Mount Sinai School of Medicine
New York New York, 10025, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Ohio State University Medical Center (OSUMC)
Columbus Ohio, 43210, United States
ProMedica Toledo Hospital
Toledo Ohio, 43606, United States
South Oklahoma Heart Research
Oklahoma City Oklahoma, 73135, United States
Newton Clinical Research
Oklahoma City Oklahoma, 73159, United States
Oklahoma Heart Institute
Tulsa Oklahoma, 74104, United States
Oregon Health & Science University (OHSU)
Portland Oregon, 97239, United States
PeaceHealth, Sacred Heart Physicians
Springfield Oregon, 97477, United States
Research Institute of Lancaster General Health
Lancaster Pennsylvania, 17602, United States
Drexel University College of Medicine
Philadelphia Pennsylvania, 19102, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
North Dallas Research Associates
Dallas Texas, 75069, United States
Texas Health Research and Education Insitute
Dallas Texas, 75231, United States
Southwest Family Medicine Associates
Dallas Texas, 75235, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Schnitzler Cardiovascular Consultants
San Antonio Texas, 78229, United States
University of Vermont Medical Center
Burlington Vermont, 05401, United States
Virginia Commonwealth University Medical College of Virginia
Richmond Virginia, 23298, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States
Unity Point Health
Madison Wisconsin, 53713, United States
University of Wisconsin - Madison
Madison Wisconsin, 53792, United States
London Health Sciences Centre
London Ontario, N6A 5, Canada
Mount Sinai Hospital
Toronto Ontario, M5G 1, Canada
Ecogene-21
Chicoutimi Quebec, G7H 7, Canada
CIUSSS de l'Estrie - CHUS
Sherbrooke Quebec, J1G 2, Canada
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec , G1V 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

196

Study ID:

NCT03254485

Recruitment Status:

Completed

Sponsor:


Akebia Therapeutics

How clear is this clinincal trial information?

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