Trial · Interventional
CompletedPhase 2Registry dataA Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 46 participants (actual)
- Sponsor
- Stealth BioTherapeutics Inc. · Industry
- Design
- Randomized · Quadruple masking
- Countries
2 countries
Germany, Serbia
- Start
- 2 Sept 2016
- Primary completion
- 4 May 2017
- Completion
- 2 Jun 2017
- First posted
- 27 Jun 2016 (estimated)
- Last update posted
- 7 Sept 2017
- Conditions
- Chronic Heart Failure
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
NCT028140972 Sept 2016 to 2 Jun 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4 weeks treatment with subcutaneous MTP-131 (elampretide) on left ventricular function.
Interventions
- elamipretideDrug
- PlaceboDrug
Arms2
Experimental
40 mg elamipretide
40 mg elamipretide once daily for 28 consecutive days
Placebo comparator
Placebo
Placebo once daily for 28 consecutive days
Primary outcomes1
Outcomes the sponsor listed as primary.
Compare the delta in E/e' at rest exercise measured with echocardiography between the elamipretide and placebo groups
Time frame · 4 weeks
Secondary outcomes(4)
Compare the change at rest and during submaximal stress in LV systolic global longitudinal strain (GLS) between the elamipretide and placebo groups at the end of the 4-week treatment period
Time frame · 4 weeks
Compare the change in 6-minute walking distance, between the elamipretide and placebo groups at the end of the 4-week treatment period
Time frame · 4 weeks
Compare the change in NT-proBNP, between the elamipretide and placebo groups at the end of the 4-week treatment period
Time frame · 4 weeks
Compare the percent of patients on elamipretide versus placebo presenting with TEAEs and SAEs, including changes in biomarkers of myocardial damage and changes in markers of renal function
Time frame · 4 weeks
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 40 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.