Status:
COMPLETED
A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
Lead Sponsor:
Akebia Therapeutics
Collaborating Sponsors:
Cyclerion Therapeutics
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2019
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT03254485
Start Date
November 7 2017
End Date
August 19 2019
Last Update
September 15 2022
Active Locations (62)
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1
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States, 85016
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
3
University of Arizona
Tucson, Arizona, United States, 85724
4
Cardiology and Medicine Clinic
Little Rock, Arkansas, United States, 72204