Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure

What Was Tested

This registered phase 2, phase 3 trial tested Relaxin (Serelaxin).

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

48 hour iv infusion of placebo.

The registry classes the interventions as drug.

More on the Plan

This is an international, randomized, double-blind, placebo-controlled, Phase II/III trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure.

The Phase II pilot study has completed; the Phase III main portion of the trial is ongoing.

Who Took Part

1161 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: Hospitalized for acute heart failure. Dyspnea at rest or with minimal exertion. Able to provide informed consent. Systolic blood pressure \> 125 mmHg.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: use of other iv therapies for acute heart failure; fever or sepsis; recent major neurologic event.

How the Study Was Run

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

The participants were allocated by chance, so the Relaxin (Serelaxin) group and the comparison group should start out alike.

The Relaxin (Serelaxin) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Relaxin (Serelaxin), so expectations could not easily colour the readings.

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

It started in 2007-10 with completion listed for 2012-09.

It ran at 3 sites in United States (2) and Israel (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Relief of dyspnea in acute heart failure (time frame: Up to day 5).

It also tracked 2 secondary outcomes, for example Days alive and out of hospital.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Relaxin (Serelaxin) in 1161 people.

With 1161 participants it is a large trial for this field.

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

More context: the Relaxin (Serelaxin) compound page, all human trials.