Relaxin Therapy for Atrial Fibrillation

NCT07359872 — Phase 1 / Phase 2, Not yet recruiting, 208 participants, Deeptankar DeMazumder

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RegistryNCT07359872, acronym Relax-in-AF
StatusNot yet recruiting
PhasePhase 1 / Phase 2
Study typeInterventional; randomized, crossover, masking: quadruple, treatment
Enrollment208 (Estimated)
SponsorDeeptankar DeMazumder (Fed); collaborators: Relaxera Pharmaceuticals, McGowan Institute for Regenerative Medicine, University of Pittsburgh, Relaxera Pharmazeutische Gesellschaft mbH & Co. KG
ConditionsAtrial Fibrillation (AF), Arrhythmia, Oxidative Stress, Stroke, Major Cardiovascular Event, Heart Failure, Catheter Ablation, Ablation of Atrial Fibrillation
InterventionsRelaxin, Placebo (Drug)
Datesstart 2027-01-01 (estimated), primary completion 2030-12-31 (estimated), completion 2030-12-31 (estimated), first posted 2026-01-22, last updated 2026-01-22

Related Papers Related Patents Related Grants Related Experts
All trials for Atrial Fibrillation (AF) All trials for Arrhythmia All trials of Relaxin All trials of Placebo

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Standard of care (including ablation) + Placebo x 9mo, then crossover to Relaxin therapy x 3moExperimentalDrug: Relaxin; Drug: PlaceboPatients 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.
Standard of care (including ablation) + Relaxin therapy x 9mo, then crossover to Placebo x 3moExperimentalDrug: Relaxin; Drug: PlaceboPatients 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.
  • Relaxin (Drug): subcutaneous injections of Relaxin once daily
  • Placebo (Drug): subcutaneous injections of Placebo once daily

+Outcome measures

Primary outcomes

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [390 days]: The Primary Safety Outcome includes the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
  • Ratio of the average daily AF burden before and after treatment [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Investigators