Relaxin Therapy for Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Relaxin, Placebo.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Arrhythmia, Oxidative Stress, Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Relaxin
subcutaneous injections of Relaxin once daily - Drug Placebo
subcutaneous injections of Placebo once daily
Primary outcome measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 390 days]
- Ratio of the average daily AF burden before and after treatment [Time frame: 390 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07359872 · 1923002