Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

What Was Tested

In this phase 2 trial, researchers set out to test SS-31 (Elamipretide).

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Placebo once daily for 28 consecutive days.

The registry classes the interventions as drug.

More on the Plan

Each treatment group went through 3 distinct periods: Screening, Treatment, and Follow up.

Who Took Part

Enrollment: 71 actual participants took part.

It was open to people of any sex aged from 40 years up to 80 years.

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

Examples of who could join: Willing and able to provide signed informed consent form (ICF) prior to participation in any study-related procedures. Age ≥40 and ≤80 years. A known history of chronic ischemic or non-ischemic cardiomyopathy of at least 6 months duration from the time of the initial diagnosis. In normal sinus rhythm (electrocardiogram documented) at Screening and Day 1 and no history of atrial fibrillation in the past 12 months. No hospitalization related to HF within 1 month prior to the Screening Visit.

The full record lists 11 inclusion and 26 exclusion criteria; among the exclusions: any contraindication to mri scanning; left ventricular end diastolic dimension (lvedd) indexed to body surface area is \> 45 mm/m2; coronary or peripheral revascularization procedures, valvular procedures, or any major surgical procedure 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.

Random assignment meant chance, not the researchers, decided who got SS-31 (Elamipretide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2016-06 with completion listed for 2017-09.

It ran at 15 sites in Italy (8), Netherlands (5) and United Kingdom (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Left Ventricular End Systolic Volume (ml) (time frame: Baseline to Week 4).

It also tracked 20 secondary outcomes, for example Change in Left Ventricular Ejection Fraction (% of Blood Volume), Change in Left Ventricular End Diastolic Volume (ml) as Measured by MRI, Change in Left Ventricular Stroke Volume (ml), Change in Left Ventricular Cardiac Output (L/Min), Change in Left Ventricular Myocardial Mass (g) and Change in Right Ventricular End Systolic Volume (mL).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of SS-31 (Elamipretide) in 71 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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