Relaxin Therapy for Atrial Fibrillation

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Relaxin — DRUG
  subcutaneous injections of Relaxin once daily
• Placebo — DRUG
  subcutaneous injections of Placebo once daily

Study Details

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.

Key Dates

First listed

Jan 22, 2026

Start date

Jan 1, 2027

Status verified

Jan 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

208 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 390 days ]

Central Contacts

• Project Manager
  (412) 822-2222

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