A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure

What Was Tested

The trial (phase 1) is built around SS-31 (Elamipretide).

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (experimental).

The registry classes the interventions as drug.

Who Took Part

36 actual participants took part.

It was open to people of any sex aged from 45 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Chronic ischemic or non-ischemic cardiomyopathy of at least 6 months duration from the time of the initial diagnosis. Diagnosis of NYHA Class II or III HF for a minimum of 6 months prior to the Screening Visit. HF is considered to be stable and no hospitalization for HF has occurred within the previous 3 months prior to the Screening visit. Females of child-bearing potential must have a negative serum pregnancy test at the Screening Visit and Day 1.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: LV end-diastolic dimension (LVEDD), by the same method as qualifying LVEF, is \>80 mm or LVEDD indexed to body surface area is \>0.45; coronary or peripheral artery revascularization procedure within 2 months prior to the screening visit; an acute myocardial infarction within 3 months prior to the screening visit.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the SS-31 (Elamipretide) group and the comparison group should start out alike.

The SS-31 (Elamipretide) group and the comparison group ran side by side rather than switching.

As a double-blind SS-31 (Elamipretide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2014-07 with completion listed for 2015-04.

It ran at 1 site in Bulgaria.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of Adverse Events (time frame: Assessed up to Day 7).

It also tracked 1 secondary outcome, for example Left ventricular ejection fraction assessed by 2-D echocardiography.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of SS-31 (Elamipretide) in 36 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the SS-31 (Elamipretide) compound page, all human trials.