Relaxin Therapy for Atrial Fibrillation

Обзор

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.

Вмешательства

• Препарат Relaxin
  subcutaneous injections of Relaxin once daily
• Препарат Placebo
  subcutaneous injections of Placebo once daily

Первичные конечные точки

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: 390 days]
• Ratio of the average daily AF burden before and after treatment [Срок оценки: 390 days]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07359872 · 1923002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗