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

What Was Tested

In this phase 3 trial, researchers set out to test Relaxin (Serelaxin).

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

Patients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 876 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 at screening and at the time of randomization. Pulmonary congestion on chest radiograph. Brain natriuretic peptide (BNP) ≥500 pg/mL or NT-proBNP ≥2,000 pg/mL. Systolic BP ≥125 mmHg at the start and at the end of screening.

The full record lists 9 inclusion and 6 exclusion criteria; among the exclusions: dyspnea primarily due to non-cardiac causes; clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.

How the Study Was Run

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

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.

As a double-blind Relaxin (Serelaxin) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2014-03-12 with completion listed for 2017-03-27.

It ran at 132 sites in Japan (52), China (18), South Korea (14), Taiwan (10), India (8) and Philippines (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change (time frame: through day 5).

It also tracked 13 secondary outcomes, for example Time to WHF, Dyspnea by VAS-AUC Changes, Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization, Time to Re-hospitalization Due to Heart Failure and Renal Impairment, Time to In-hospital Worsening Heart Failure Through Day 5 and Use of Loop Diuretic and Vasoactive Agents.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Relaxin (Serelaxin) in 876 people.

With 876 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.