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Cardiac Rehabilitation in Patients With High-Genetic-Risk Arrhythmogenic Cardiomyopathy: The HGEN-CARE-AC Trial
Sponsor: Juan Jiménez Jáimez
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 main question it aims to answer 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? As secondary objectives, the study will thoroughly evaluate 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 aims to assess the psychological benefits of the program, analyzing its effects on health-related quality of life, anxiety, and depression levels. Researchers will compare the experimental group undergoing cardiac rehabilitation to a control group receiving conventional physical restriction guidelines to determine if the program is both safe and comprehensive.
Official title: Exploratory Randomized Clinical Trial on the Safety and Feasibility of a Cardiac Rehabilitation Programme in Patients With High-Genetic-Risk Arrhythmogenic Cardiomyopathy (HGEN-CARE-AC Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-09
Completion Date
2028-09
Last Updated
2026-07-16
Healthy Volunteers
No
Interventions
Cardiac Rehabilitation Programme
A structured, personalized, and supervised cardiac rehabilitation program based on moderate-intensity physical exercise, tailored specifically for high-risk genotype-positive arrhythmogenic cardiomyopathy (ACM) patients. The intervention follows the FITT (Frequency, Intensity, Time, Type) principles: Frequency: 2 to 3 supervised sessions per week for a total duration of 12 consecutive weeks. Intensity: Strictly restricted to a moderate-intensity zone. The target training heart rate is set individually, bounded between the first ventilatory threshold (VT1) and a safe ceiling well below the second ventilatory threshold (VT2) or any individual arrhythmic thresholds identified during baseline cardiopulmonary exercise testing (CPET). Time: Each session lasts between 90 minutes, including a 10-minute progressive warm-up and a 10-minute cool-down phase. Type: Continuous aerobic exercise primarily performed on a cycle ergometer o