CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 196 enrolled
Drug / intervention
IW-1973 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age ≥45 years, ambulatory
  • ✓Ejection fraction ≥40%
  • ✓Peak VO2 <80% of age- and sex-adjusted predicted values
  • ✓Evidence of HF syndrome: prior HF hospitalization/ED visit, elevated BNP/NT-proBNP, echocardiographic findings (LV hypertrophy, LA enlargement, or diastolic dysfunction), or hemodynamic evidence of elevated filling pressures
Key exclusion· 8
  • ✕Acute coronary syndrome or percutaneous coronary intervention within 30 days
  • ✕Cardiac transplantation (prior or planned)
  • ✕Cardiac surgery (bypass graft, mechanical support, or other cardiac surgery) within 3 months or planned
  • ✕Severe chronic obstructive coronary disease with chronic oxygen dependence

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03254485
NCT03254485Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 Over 12 Weeks in Patients With Heart Failure With Preserved Ejection Fraction

Akebia Therapeutics·interventional·Posted Aug 18, 2017·Updated Sep 15, 2022

In Brief

A Phase 2 clinical trial evaluating IW-1973 and Placebo Oral Tablet for Heart Failure With Preserved Ejection Fraction. Completed, enrolled 196 participants across 62 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure With Preserved Ejection Fraction
CountriesCanada, United States
CollaboratorsCyclerion Therapeutics

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 18, 2017
Enrollment StartNov 7, 2017
Primary CompletionAug 19, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.9 years ago

Interventions

IW-1973drug

Oral Tablet

Placebo Oral Tabletdrug

Oral Tablet