Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

What Was Tested

The trial (phase 2) is built around Relaxin (Serelaxin).

This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute heart failure.

In addition safety and effects on renal function and biomarkers will be assessed.

It had two arms (groups): RLX030 (experimental) and Placebo (placebo comparator).

RLX030 as intravenous infusion for 20 hours.

Matching placebo as intravenous infusion for 20 hours.

The registry classes the interventions as drug.

Who Took Part

The registry lists 71 actual participants took part.

It was open to people of any sex aged from 18 years up to 87 years.

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

Examples of who could join: Patients hospitalized or requiring admission to hospital for management of acute heart failure within the previous 48 hours. Pulmonary wedge pressure above or equal to18 mmHg determined by right heart catheterization.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: systolic blood pressure below 115 mmhg; acute coronary syndrome in previous 45 days; treatment with mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device).

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.

Blinding on both sides kept the participants and researchers unaware of who received Relaxin (Serelaxin).

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

It started in 2012-03 with completion listed for 2013-01.

It ran at 20 sites in Russia (8), Germany (6), Argentina (2), Poland (2), Italy (1) and Netherlands (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Peak change from baseline of PCWP (pulmonary capillary wedge pressure) (time frame: baseline, after 8 and 20 hrs treatment).

It also tracked 16 secondary outcomes, for example Change over time of PCWP (pulmonary capillary wedge pressure), Change over time of systemic vascular resistance (SVR), Change over time of pulmonary vascular resistance (PVR), Change over time of pulmonary arterial pressure (PAP), Change over time of pulmonary and peripheral oxygen saturation and Change over time on calculated creatinine clearance.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relaxin (Serelaxin) in 71 people.

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.