Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

What Was Tested

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

It had two arms (groups): Serelaxin + Standard of Care (experimental) and Standard of Care (SOC) (other).

All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

The registry classes the interventions as drug.

More on the Plan

This study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in Acute Heart Failure (AHF).

Who Took Part

The registry lists 2666 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: Systolic blood pressure ≥ 125 mmHg. Admitted for Acute Heart Failure (AHF). Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: dyspnea (non-cardiac causes); T \> 38.5°C; clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Relaxin (Serelaxin) and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Relaxin (Serelaxin) study: the participants and staff both knew the treatment.

It started in 2014-01-31 with completion listed for 2017-03-26.

It ran at 357 sites in Germany (86), France (43), Spain (39), Italy (34), Russia (27) and Poland (14).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14, Length of Index Hospital Stay, Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients and Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Relaxin (Serelaxin) in 2666 people.

With 2666 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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