Relaxin Therapy for Atrial Fibrillation

NCT07359872 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 1923002
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

randomized controlled crossover trial; Randomized clinical trial

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  The Primary Safety Outcome includes the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  390 days

• Ratio of the average daily AF burden before and after treatment

  The Primary Efficacy Outcome includes the distribution of the ratio of the average daily AF burden before and after treatment over time. The daily AF burden is defined as the daily AF duration multiplied by the number of AF events including atrial ectopy.

  390 days

Study Arms (2)

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

Drug: Relaxin; Drug: Placebo

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) Relaxin for the first 9 months; and then (2) Placebo, instead of Relaxin, for another 3 months.

Drug: Relaxin; Drug: Placebo

Interventions

Relaxin DRUG

subcutaneous injections of Relaxin once daily

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

Placebo DRUG

subcutaneous injections of Placebo once daily

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deeptankar DeMazumder: lead
• Relaxera Pharmaceuticals: collaborator
• McGowan Institute for Regenerative Medicine, University of Pittsburgh: collaborator
• Relaxera Pharmazeutische Gesellschaft mbH & Co. KG: collaborator

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Stroke; Heart Failure

Interventions

Relaxin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Deeptankar DeMazumder, MD, PhD

  (1) VA Pittsburgh Health System; (2) McGowan Institute for Regenerative Medicine.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

(412) 822-2222

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician in Cardiac Electrophysiology

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 22, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared as allowed by applicable VA, state, federal and IP rules and policies.
• Access Criteria: Data will be shared as allowed by applicable VA, state, federal and IP rules and policies.