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临床试验/NCT07359872
NCT07359872尚未招募1 期

Relaxin Therapy for Atrial Fibrillation

Deeptankar DeMazumder0 个研究点目标入组 208 人开始时间: 2027年1月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
208

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Diagnosed with AF and scheduled for elective catheter ablation for AF

排除标准

  • 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

研究者

发起方
Deeptankar DeMazumder
申办方类型
Fed
责任方
Sponsor Investigator
主要研究者

Deeptankar DeMazumder

Attending Physician in Cardiac Electrophysiology

VA Pittsburgh Healthcare System

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