Clinical Trial

Cardiac Rehabilitation in Patients With High-Genetic-Risk Arrhythmogenic Cardiomyopathy: The HGEN-CARE-AC Trial

Study acronym: HGEN-CARE-AC
Not Yet Recruiting
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Summary
The goal of this clinical trial is to evaluate a structured and personalized cardiac rehabilitation program for patients diagnosed with arrhythmogenic cardiomyopathy (ACM) who carry high-risk genetic mutations. Historically, physical exercise has been strictly restricted in these patients due to the potential risk of triggering life-threatening arrhythmias and accelerating structural heart disease. However, complete inactivity leads to severe physical deconditioning and reduced quality of life. This study aims to address this clinical dilemma by investigating a safe way to prescribe exercise. The primary research question is: Is a supervised, moderate-intensity exercise program safe, and does it avoid increasing the risk of cardiac arrhythmias or worsening right ventricular function compared to standard physical restriction? Secondary objectives include the evaluation of the impact of this tailored physical intervention on the participants' functional capacity, specifically measuring changes in physical fitness and peak oxygen consumption through cardiovascular testing. Additionally, the trial assesses the psychological benefits of the program, analyzing its effects on health-related quality of life, anxiety, and depression levels. The experimental group undergoing cardiac rehabilitation will be compared to a control group receiving conventional physical restriction guidelines to determine if the program is both safe and comprehensive.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-07-10.
Trial Details
NCT Number NCT07708311
Lead Sponsor Juan Jiménez Jáimez
Collaborators: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Conditions Arrhythmogenic Cardiomyopathy (AC, ARVD/C)
Enrollment 70 participants
Start Date 2026-09
Primary Completion 2026-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-20