Phase 2
N=196
A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
Heart Failure With Preserved Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT03254485 ↗Enrolled (actual)
196
Serious AEs
9.7%
Results posted
Sep 2022
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Study Drug-related TEAEs — 61; 4; 6; 72 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IW-1973 (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Akebia Therapeutics
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Study Drug-related TEAEs |
61; 4; 6; 72; 9; 1 | — |
| PRIMARY Change From Baseline in Peak Oxygen Consumption (VO2) at Week 12 |
0.04; -0.26 | =0.3681 |
| SECONDARY Change From Baseline in 6-minute Walk Test (6MWT) Distance at Week 12 |
58.12; 41.38 | =0.2817 |
| SECONDARY Change From Baseline in Ventilatory Efficiency at Week 12 |
0.564; 0.267 | =0.6508 |
| SECONDARY CPET Responders at Week 12 |
17; 13 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03254485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.