An interventional study of Cardiac Rehabilitation Programme in Arrhythmogenic Cardiomyopathy (AC, ARVD/C), sponsored by Juan Jiménez Jáimez. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Juan Jiménez Jáimez · Not applicable, Interventional, and Treatment
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.
Study Design:
This is an exploratory, randomized, parallel-group clinical trial designed to assess the safety and feasibility of a structured cardiac rehabilitation program for patients with high-genetic-risk arrhythmogenic cardiomyopathy (ACM). Participants will be randomized in a 1:1 ratio to either the experimental intervention group or a control group receiving standard-of-care physical restriction guidelines.
Interventions:
Data Acquisition and Monitoring:
Safety and structural remodeling will be monitored throughout the study period. Safety assessments include continuous surveillance for adverse events (e.g., symptomatic arrhythmias, syncope, or hospitalizations). Structural and functional cardiac changes will be quantified through standardized advanced cardiac imaging techniques (echocardiography) and cardiopulmonary exercise testing at baseline and follow-up time points. Psychometric status will be evaluated using validated questionnaires to capture changes in health-related quality of life, anxiety, and depression.
Statistical Analysis Plan:
Continuous variables will be reported as mean ± standard deviation (or median and interquartile range for non-normal distributions), while categorical variables will be presented as frequencies and percentages. Longitudinal changes from baseline to follow-up will be evaluated using mixed-effects models for repeated measures, accounting for inter-individual variability.
An exploratory subgroup analysis will be conducted to assess the consistency of the intervention's effects across predefined patient strata. Differences in safety and efficacy outcomes (such as changes in VO2 peak and left ventricular ejection fraction) will be evaluated, stratified by:
Statistical comparisons between subgroups will be performed using independent t-tests or ANOVA for normally distributed continuous data, and Mann-Whitney U or Kruskal-Wallis tests for non-normally distributed data. Categorical variables will be assessed using Chi-square or Fisher's exact tests. This exploratory analysis is intended to identify potential heterogeneous treatment effects; all tests will be two-tailed, with a p-value \< 0.05 considered statistically significant.
47 studies on the registry are indexed under Arrhythmogenic Right Ventricular Dysplasia; 24 are open to participants now.
This study's planned enrollment of 70 is above the median of 34 across 15 interventional studies indexed under Arrhythmogenic Right Ventricular Dysplasia.
Browse Arrhythmogenic Right Ventricular Dysplasia studies →This is the only study on the registry with Juan Jiménez Jáimez as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to this experimental arm will engage in a structured, personalized, and supervised physical exercise program at the hospital's specialized Cardiac Rehabilitation Unit for a duration of 12 weeks. The intervention consists of customized, moderate-intensity training sessions designed and supervised by qualified clinical personnel. Training intensity is strictly individualized, bounded by safe target heart rate thresholds and workloads derived from each participant's baseline maximal cardiopulmonary exercise testing (CPET).
Behavioral: Cardiac Rehabilitation Programme
Participants randomized to this active comparator control arm will maintain conventional clinical care as prescribed by current guidelines for high-genetic-risk arrhythmogenic cardiomyopathy. This involves strict adherence to physical restriction guidelines, including complete abstinence from competitive, high-intensity sports and strenuous physical exercise. Participants are encouraged to maintain basic activities of daily living and light leisure-time physical habits, serving as a direct control baseline to evaluate safety outcomes.
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
Composite safety endpoint of clinical and arrhythmic events.
Safety of the 12-week supervised moderate-intensity exercise program will be evaluated as a composite endpoint defined by the absence of a clinically relevant increase in ventricular arrhythmias or major adverse cardiovascular events. Arrhythmic safety includes ventricular arrhythmia burden (sustained and non-sustained ventricular tachycardia) detected via prolonged ambulatory Holter monitoring and ICD (Implantable Cardioverter-Defibrillator) interrogation logs. Clinical safety events track the incidence of major complications during the study period, including sudden cardiac death, appropriate or inappropriate ICD therapies (shocks or antitachycardia pacing), and arrhythmic syncope, comparing the intervention cohort against the standard physical restriction control group.
Time frame: From baseline up to 6 months.
Change from baseline in peak oxygen consumption (VO2 peak)
Change in peak oxygen consumption (VO2 peak). Breath-by-breath gas exchange measurements (oxygen uptake in mL/min and carbon dioxide production in mL/min) and total body weight in kilograms (Kg) will be combined to report VO2 peak in mL/kg/min. This value represents the highest 30-second average of oxygen consumption attained during the maximal effort stage of a cardiopulmonary exercise test (CPET).
Time frame: Baseline and 12 weeks
Change from baseline in metabolic equivalents (METs)
Preliminary clinical efficacy on functional capacity will be evaluated using objective cardiopulmonary metrics. Change in metabolic equivalents (METs). Peak oxygen uptake (mL/kg/min) and the resting metabolic constant (3.5 mL/kg/min) will be combined to report the peak METs achieved during maximal cardiopulmonary exercise testing (CPET). This value is calculated as the ratio of peak oxygen consumption to the resting metabolic rate.
Time frame: Baseline and 12 weeks
Change from baseline in 6-minute walk distance
Change in total distance walked during the 6-Minute Walk Test (6MWT). Walking speed (m/s) and the duration of the test (6 minutes) will be combined to report the total distance covered in meters. The distance is measured from start to finish based on the participant's total displacement during the 6-minute period.
Time frame: Baseline and 12 weeks.
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
The psychological impact of the rehabilitation program will be assessed using validated psychometric scales. Change in anxiety and depression levels. Individual item scores (responses to 14 questions) will be combined to report the total HADS score. This scale aggregates responses to assess anxiety and depression symptoms; higher scores indicate greater symptom severity (a worse outcome). Unit of Measure: Scale (on a scale of 0 to 42)
Time frame: Baseline and 6 months.
Change from baseline in SF-36 health-related quality of life score
The psychological impact of the rehabilitation program will be assessed using validated psychometric scales. Change in health-related quality of life. The 36 individual item responses will be combined and weighted using standard scoring algorithms to report the SF-36 summary scores (Physical and Mental Component Summary scores); higher scores indicate a better health-related quality of life (a better outcome). Unit of Measure: Scale (on a scale of 0 to 100)
Time frame: Baseline and 6 months.
Change from baseline in EQ-5D-5L index score
The psychological impact of the rehabilitation program will be assessed using validated psychometric scales. Change in health-related quality of life. Responses to the 5 dimensions are combined using an official value set to report a single index score; higher scores indicate a better health state (a better outcome). Unit of Measure: Scale (0 to 1)
Time frame: Baseline and 6 months.
Change in left ventricular ejection fraction (LVEF)
Exploratory changes in the phenotypic expression of arrhythmogenic cardiomyopathy will be evaluated with echocardiogram to monitor mid-term structural remodeling. Left ventricular end-diastolic volume (mL) and end-systolic volume (mL) will be combined to report the LVEF as a percentage (%). This value is calculated as the stroke volume divided by the end-diastolic volume. Unit of Measure: Percentage (%)
Time frame: Baseline and 6 months.
Change in right ventricular ejection fraction (RVEF)
Exploratory changes in the phenotypic expression of arrhythmogenic cardiomyopathy will be evaluated with echocardiogram to monitor mid-term structural remodeling. Right ventricular end-diastolic volume (mL) and end-systolic volume (mL) will be combined to report the RVEF as a percentage (%). This value is calculated as the stroke volume divided by the end-diastolic volume. Unit of Measure: Percentage (%)
Time frame: Time Frame: Baseline and 6 months.
Change in left ventricular internal diameter
Exploratory changes in the phenotypic expression of arrhythmogenic cardiomyopathy will be evaluated with echocardiogram to monitor mid-term structural remodeling. Endocardial-to-endocardial distances in the parasternal long-axis view will be combined to report the diameter at end-diastole. Unit of Measure: Millimeters (mm)
Time frame: Baseline and 6 months.
Change from baseline in Body Mass Index (BMI)
Impact on general cardiovascular health parameters will be analyzed through BMI: Total body weight (Kg) and height (m) will be combined to report BMI in kg/m2. Unit of Measure: kg/m2
Time frame: Baseline and 12 weeks.
Change from baseline in systolic blood pressure
Impact on general cardiovascular health parameters will be analyzed through multiple blood pressure readings taken at rest will be combined (averaged) to report the systolic blood pressure. Unit of Measure: mmHg
Time frame: Baseline and 12 weeks.
Change from baseline in serum LDL cholesterol
Impact on general cardiovascular health parameters will be analyzed through LDL levels. Total cholesterol, HDL cholesterol, and triglyceride measurements will be combined using the Friedewald equation to report the calculated LDL cholesterol concentration. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks.
Change from baseline in glycated hemoglobin (HbA1c)
Glycated hemoglobin levels will be measured from venous blood samples to report the percentage of hemoglobin A1c. Unit of Measure: Percentage (%)
Time frame: Baseline and 12 weeks.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Arrhythmogenic Right Ventricular Dysplasia→