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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
Relaxin
Drugsubcutaneous injections of Relaxin once daily
Placebo
Drugsubcutaneous injections of Placebo once daily
Treatment groups
Trial outcomes
Primary outcomes
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
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.
Locations
Sponsors and contacts
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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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