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Relaxin Therapy for Atrial Fibrillation

Relaxin Therapy for Atrial Fibrillation

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07359872
Acronym
Relax-in-AF
Enrollment
208
Registered
2026-01-22
Start date
2027-01-01
Completion date
2030-12-31
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ablation of Atrial Fibrillation, Arrhythmia, Atrial Fibrillation (AF), Catheter Ablation, Heart Failure, Major Cardiovascular Event, Oxidative Stress, Stroke

Keywords

randomized controlled crossover trial, Randomized clinical trial

Brief 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.

Interventions

subcutaneous injections of Relaxin once daily

DRUGPlacebo

subcutaneous injections of Placebo once daily

Sponsors

Deeptankar DeMazumder
Lead SponsorFED
Relaxera Pharmaceuticals
CollaboratorUNKNOWN
McGowan Institute for Regenerative Medicine, University of Pittsburgh
CollaboratorUNKNOWN
Relaxera Pharmazeutische Gesellschaft mbH & Co. KG
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0390 daysThe 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 treatment390 daysThe 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.

Contacts

CONTACTProject Manager
(412) 822-2222
PRINCIPAL_INVESTIGATORDeeptankar DeMazumder, MD, PhD

(1) VA Pittsburgh Health System; (2) McGowan Institute for Regenerative Medicine.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026