Relaxin Therapy for Atrial Fibrillation

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDeeptankar DeMazumder

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Diagnosed with AF and scheduled for elective catheter ablation for AF

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Relaxin

    Drug

    subcutaneous injections of Relaxin once daily

  • Placebo

    Drug

    subcutaneous injections of Placebo once daily

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Standard of care (including ablation) + Placebo x 9mo, then crossover to Relaxin therapy x 3moExperimental treatment 2 interventions
Group B: Standard of care (including ablation) + Relaxin therapy x 9mo, then crossover to Placebo x 3moExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
390 days
2

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.

Time frame
390 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Deeptankar DeMazumder

Lead sponsor

VA Pittsburgh Healthcare System

Sponsor institution

Relaxera Pharmaceuticals

Collaborator

McGowan Institute for Regenerative Medicine, University of Pittsburgh

Collaborator

Relaxera Pharmazeutische Gesellschaft mbH & Co. KG

Collaborator

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