A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure

What Was Tested

The trial (phase 2) is built around SS-31 (Elamipretide).

This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac and renal effects of short term treatment with elamipretide in patients hospitalized with congestion due to heart failure.

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

Placebo once daily for 7 consecutive days.

The registry classes the interventions as drug.

Who Took Part

The registry lists 308 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: A history of chronic heart failure for at least 1 month. Systolic blood pressure \>90 mmHg and considered to be haemodynamically stable, in the opinion of the Investigator. NT-proBNP \>1500 pg/ml or BNP \>500 pg/ml.

The full record lists 8 inclusion and 22 exclusion criteria; among the exclusions: invasive cardiac investigation and/or treatment (i.e. coronary angiography, percutaneous coronary intervention \[pci\] or surgery) or other surgical procedure planned in the next 4 weeks; use of intravenous radiographic contrast agent within 72 hours prior to screening or planned use during the study; severe, in the investigators opinion, uncorrected valve disease or congenital heart disease as the cause for cardiac decompensation.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received SS-31 (Elamipretide).

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

It started in 2016-10-20 with completion listed for 2017-11-27.

It ran at 46 sites in Spain (9), Netherlands (7), Bulgaria (6), Serbia (6), Hungary (4) and Latvia (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in NT-proBNP between Baseline and Day 8/Early Discharge (time frame: Baseline to Day 8).

It also tracked 10 secondary outcomes, for example Half-life (T1/2), Area under the concentration - time curve from 0-24 h (AUC 0-24), Area under the concentration - time curve from 0- infinity (AUC 0-∞) and Peak Plasma Concentration (Cmax).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of SS-31 (Elamipretide) in 308 people.

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.