Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure

What Was Tested

In this phase 2 trial, researchers set out to test Relaxin (Serelaxin).

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

Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 321 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: Body weight of ≤ 160 kg. Subjects with compensated CHF (NYHA Class II - III) at time of screening with a prior documented history of chronic heart failure. NT-proBNP \>300 pg/ml (according to central measurement) at visit 1. Subjects treated with appropriate and guideline-indicated CHF standard of care.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: current acute decompensated hf; any major solid organ transplant recipient or planned anticipated organ transplant within 1 year.

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.

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, care provider, investigator and outcomes assessor.

It started in 2014-05 with completion listed for 2015-09.

It ran at 52 sites in Germany (11), United States (9), Romania (5), Spain (5), Turkey (Türkiye) (5) and Italy (4).

What Was Measured

Primary outcome: Percentage of Participants With Chronic Heart Failure (CHF) Who Develop Anti-serelaxin Antibodies at Any Time Following Repeat Administration of IV Continuous Infusions of Serelaxin Administered for up to 48 Hours in 16 Weeks (time frame: 16 weeks).

It also tracked 8 secondary outcomes, for example Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relaxin (Serelaxin) in 321 people.

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.