Relaxin Therapy for Atrial Fibrillation (Relax-in-AF)

Deeptankar DeMazumder

Status and phase: Begins enrollment in 10 months; Phase 2; Phase 1

Conditions: Arrhythmia; Stroke; Oxidative Stress; Atrial Fibrillation (AF); Ablation of Atrial Fibrillation; Heart Failure; Major Cardiovascular Event; Catheter Ablation

Treatments: Drug: Relaxin; Drug: Placebo

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT07359872

1923002

Details and patient eligibility

About

Atrial fibrillation (AF) is the most common heart rhythm disorder. The presence of AF increases the risk of death and is associated with a 5-6-fold increase in stroke incidence, due almost exclusively to thrombus formation in the heart. Current therapies for AF are limited. The evaluation of new, more effective treatments for preventing AF recurrence remains a critical unmet clinical need. AF is considered a progressive disease that increases in prevalence with age and can convert from "paroxysmal" to "persistent" to "permanent" AF in a single individual. This progression results, in part, from high oxidative stress and progressive adverse electrical changes in the heart. Compelling preclinical and clinical data indicate that Relaxin, a naturally occurring peptide hormone, may reverse the electrical remodeling. Thus, our overall objective is to investigate the effects of Relaxin in Veterans who have failed medical management for symptomatic AF and is referred to Cardiac Electrophysiology Laboratory for catheter ablation and pulmonary vein isolation. We will determine whether Relaxin therapy, in addition to the standard of care, counteracts the oxidative stress-related electrical derangement and reduces the post-ablation AF burden. A unique aspect of this proposal is that it is based in part on observations derived from the basic, translational and computational labs of the PI and co-investigators and from the observations by the PI while caring for patients with AF. As such, this proposal represents a true progression from the bench to the bedside. If successful, our findings may lead to the design of a new, more effective treatment for a major unmet public health problem in the United States as well as the world.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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
• Patients diagnosed with "permanent" AF, complete heart block, or a reversible cause of AF (e.g., transient thyrotoxicosis)
• Patients that require antiarrhythmic medication to started or continued during and after the ablation procedure.
• Patients unable to tolerate Relaxin therapy or unable or unwilling to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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208 participants in 2 patient groups

Standard of care (including ablation) + Placebo x 9mo, then crossover to Relaxin therapy x 3mo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Relaxin

Standard of care (including ablation) + Relaxin therapy x 9mo, then crossover to Placebo x 3mo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Relaxin