Recombinant Human Relaxin for the Treatment of Decompensated CHF

What Was Tested

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

It had three arms (groups): Placebo (placebo comparator), one (experimental) and one (experimental).

Participants receive diluent via continuous IV infusion for 48 hours.

The registry classes the interventions as drug.

More on the Plan

Serial evaluations will include cardiac and renal function, as well as safety and tolerability.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to people of any sex aged from 19 years with no upper age limit.

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

Examples of who could join: Decompensated chronic CHF (NYHA Class III-IV). PCWP \> 22 mmHg.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: acute chf; acute coronary syndrome; hypotension or shock.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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

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 and investigator.

It started in 2006-11 with completion listed for 2007-01.

It ran at 2 sites in Russia (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Cardiac hemodynamics (time frame: Baseline through 27 hours post-infusion or discharge from the hospital).

It also tracked 2 secondary outcomes, for example Renal function and Safety and Tolerability assessed by number of patients with adverse events (AEs).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relaxin (Serelaxin) in 11 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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