Relaxin Therapy for Atrial Fibrillation

Summary

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.

Conditions

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

Interventions

DRUG

Relaxin

subcutaneous injections of Relaxin once daily

DRUG

Placebo

subcutaneous injections of Placebo once daily

Sponsors & Collaborators

• Relaxera Pharmaceuticals

  collaborator UNKNOWN

• McGowan Institute for Regenerative Medicine, University of Pittsburgh

  collaborator UNKNOWN

• Relaxera Pharmazeutische Gesellschaft mbH & Co. KG

  collaborator UNKNOWN

• Deeptankar DeMazumder

  lead FED

Principal Investigators

• Deeptankar DeMazumder, MD, PhD · (1) VA Pittsburgh Health System; (2) McGowan Institute for Regenerative Medicine.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-01

Primary Completion

2030-12-31

Completion

2030-12-31

FDA Drug

Yes