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

January 21, 2026 updated by: Deeptankar DeMazumder
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Project Manager
  • Phone Number: (412) 822-2222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Relaxin
subcutaneous injections of Relaxin once daily
Drug: Placebo
subcutaneous injections of Placebo once daily
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.
Drug: Relaxin
subcutaneous injections of Relaxin once daily
Drug: Placebo
subcutaneous injections of Placebo once daily

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deeptankar DeMazumder

Collaborators

Relaxera Pharmaceuticals
McGowan Institute for Regenerative Medicine, University of Pittsburgh
Relaxera Pharmazeutische Gesellschaft mbH & Co. KG

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1923002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared as allowed by applicable VA, state, federal and IP rules and policies.

IPD Sharing Time Frame

Data will be shared as allowed by applicable VA, state, federal and IP rules and policies.

IPD Sharing Access Criteria

Data will be shared as allowed by applicable VA, state, federal and IP rules and policies.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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