Relaxin Therapy for Atrial Fibrillation

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Relaxin (Serelaxin).

Atrial fibrillation (AF) is the most common heart rhythm disorder.

Current therapies for AF are limited.

It had two arms (groups): Standard of care (including ablation) + Placebo x 9mo, then crossover to Relaxin therapy x 3mo (experimental) and Standard of care (including ablation) + Relaxin therapy x 9mo, then crossover to Placebo x 3mo (experimental).

Patients receiving the standard of care (which includes catheter ablation) will be treatment in a double blinded manner with (1) Placebo for the first 9 months; and then (2) Relaxin, instead of Placebo, for another 3 months.

Patients receiving the standard of care (which includes catheter ablation) will be treatment in a double blinded manner with (1) Relaxin for the first 9 months; and then (2) Placebo, instead of Relaxin, for another 3 months.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 208 planned participants were the target.

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: Age ≥ 18 years. Diagnosed with AF and scheduled for elective catheter ablation for AF.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: enrollment in another greater than minimal risk study; pregnant, nursing, or sexually active females not using birth control or having been surgically sterilized; females who plan to become pregnant during the trial period.

How the Study Was Run

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

The participants were allocated by chance, so the Relaxin (Serelaxin) group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Relaxin (Serelaxin) and the comparison in turn, acting as their own control.

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 2027-01-01 with completion listed for 2030-12-31.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 390 days). Ratio of the average daily AF burden before and after treatment (time frame: 390 days).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Relaxin (Serelaxin) in 208 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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