At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 71 enrolled
Drug / intervention
4 mg elamipretide +2 moredrug
Likely dose
4 mg or 40 mg elamipretide subcutaneous injection once daily for 28 consecutive daysAI-extracted
Key inclusion· 8
- ✓Age 40–80 years
- ✓Chronic ischemic or non-ischemic cardiomyopathy with duration ≥6 months from initial diagnosis
- ✓Receiving heart failure treatment with ACE inhibitor or ARB AND evidence-based beta blocker; subjects intolerant of ACE/ARB due to renal dysfunction or hypotension are eligible
- ✓Heart failure considered stable by investigator AND HF medication doses stable for ≥1 month prior to screening
Key exclusion· 23
- ✕Left ventricular end diastolic dimension indexed to body surface area >45 mm/m²
- ✕Coronary, peripheral, or valvular revascularization procedures, or major surgery within 3 months prior to screening
- ✕Acute coronary syndrome, stroke, or transient ischemic attack within 3 months prior to screening
- ✕Obstructive or restrictive cardiomyopathy, infiltrative myocardial disease (amyloid, sarcoid), myocarditis, valvular-primary LV dysfunction, prior cardiac valve surgery, or known aortic stenosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of Multiple Subcutaneous Injections of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction
In Brief
A Phase 2 clinical trial evaluating 4 mg elamipretide, 40 mg elamipretide, and 1 other intervention for Heart Failure. Completed, enrolled 71 participants across 15 sites in 3 countries.
Detailed Summary
This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesItaly, Netherlands, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJun 2016
First PostedJun 2016
Primary CompletionSep 2017
Study CompletionOct 2017
TodayJul 2026
First PostedJun 2, 2016
Enrollment StartJun 1, 2016
Primary CompletionSep 1, 2017
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.1 years ago
Interventions
4 mg elamipretidedrug
Subcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days
40 mg elamipretidedrug
Subcutaneous injection of 40 mg elamipretide administered once daily for 28 consecutive days
Placebodrug
Subcutaneous injection of placebo administered once daily for 28 consecutive days