Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF

What Was Tested

The trial (phase 3) is built around Relaxin (Serelaxin).

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

Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.

The registry classes the interventions as drug.

More on the Plan

The AHF patients randomized to either serelaxin or placebo in the study were followed for a period of 180 days, and were required to receive standard-of-care background HF management during both the index hospitalization and post discharge according to regional or local guidelines/institutional standards.

Who Took Part

6600 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: Male or female 18 years of age, with body weight ≤160 kg. Persistent dyspnea at rest or with minimal exertion. Pulmonary congestion on chest radiograph. Systolic BP ≥125 mmHg at the start and at the end of screening. Able to be randomized within 16 hours from presentation to the hospital, including the emergency department.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: dyspnea primarily due to non-cardiac causes; temperature \>38.5°c (oral or equivalent) or sepsis or active infection requiring iv anti-microbial treatment; clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.

How the Study Was Run

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

Because people in this Relaxin (Serelaxin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2013-10-02 with completion listed for 2017-01-23.

It ran at 540 sites in United States (105), Germany (65), Argentina (34), Russia (27), Italy (26) and Spain (22).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5 (time frame: Day 5).

It also tracked 8 secondary outcomes, for example Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization, Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization, Change From Baseline in hsTroponin T Biomarker, Change From Baseline in NT-proBNP Biomarker and Change From Baseline in Cystatin C Biomarker.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Relaxin (Serelaxin) in 6600 people.

With 6600 participants it is a large trial for this field.

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

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