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

NCT07708311 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-07-20

No results posted yet for this study

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.

Conditions

  • Arrhythmogenic Cardiomyopathy (AC, ARVD/C)

Interventions

BEHAVIORAL

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

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

    collaborator OTHER

  • Juan Jiménez Jáimez

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2026-09-30
Completion
2028-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708311 on ClinicalTrials.gov