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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 62 Locations for this study
Phoenix Arizona, 85016, United States
Scottsdale Arizona, 85259, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72204, United States
La Mesa California, 91941, United States
Los Angeles California, 90036, United States
National City California, 91950, United States
Northridge California, 91325, United States
Palo Alto California, 94305, United States
Torrance California, 90509, United States
Denver Colorado, 80218, United States
Littleton Colorado, 80120, United States
Fort Lauderdale Florida, 33308, United States
Hialeah Florida, 33016, United States
Jacksonville Florida, 32216, United States
Miami Florida, 33126, United States
Pembroke Pines Florida, 33024, United States
Port Orange Florida, 32127, United States
Boise Idaho, 83712, United States
Chicago Illinois, 60611, United States
Peoria Illinois, 61602, United States
Indianapolis Indiana, 46237, United States
Kansas City Kansas, 66160, United States
Bogalusa Louisiana, 70427, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02118, United States
Burlington Massachusetts, 01805, United States
Ypsilanti Michigan, 48197, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63106, United States
Saint Louis Missouri, 63110, United States
Ridgewood New Jersey, 07450, United States
New York New York, 10025, United States
Durham North Carolina, 27710, United States
Columbus Ohio, 43210, United States
Toledo Ohio, 43606, United States
Oklahoma City Oklahoma, 73135, United States
Oklahoma City Oklahoma, 73159, United States
Tulsa Oklahoma, 74104, United States
Portland Oregon, 97239, United States
Springfield Oregon, 97477, United States
Lancaster Pennsylvania, 17602, United States
Philadelphia Pennsylvania, 19102, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75069, United States
Dallas Texas, 75231, United States
Dallas Texas, 75235, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
San Antonio Texas, 78229, United States
Burlington Vermont, 05401, United States
Richmond Virginia, 23298, United States
Tacoma Washington, 98431, United States
Madison Wisconsin, 53713, United States
Madison Wisconsin, 53792, United States
London Ontario, N6A 5, Canada
Toronto Ontario, M5G 1, Canada
Chicoutimi Quebec, G7H 7, Canada
Sherbrooke Quebec, J1G 2, Canada
Québec , G1V 4, Canada
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.