Arrhythmogenic Cardiomyopathy (AC, ARVD/C)HGEN-CARE-ACNCT07708311
Cardiac Rehabilitation in Patients With High-Genetic-Risk Arrhythmogenic Cardiomyopathy: The HGEN-CARE-AC Trial
A study testing Cardiac Rehabilitation Programme in people with Arrhythmogenic Cardiomyopathy (AC, ARVD/C), run by Juan Jiménez Jáimez.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmogenic Cardiomyopathy (AC, ARVD/C)
- What is being tested?
- Cardiac Rehabilitation Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 years of age or older at the time of signing the informed consent.
- Definite diagnosis of arrhythmogenic cardiomyopathy (ACM) according to the 2024 European Task Force criteria.
- Documented left or right ventricular involvement confirmed via transthoracic echocardiography or cardiac magnetic resonance imaging (MRI), characterized by abnormalities in regional contractility, presence of aneurysms, reduced ejection fraction, and/or late gadolinium enhancement (LGE).
- Confirmed presence of a pathogenic or likely pathogenic genetic variant in the LMNA, DSP, FLNC, TMEM43, PLN, or DES genes.
- Clinical stability maintained for 3 months or longer prior to inclusion, defined as the absence of hospital admissions, sustained ventricular arrhythmic events, or implantable cardioverter-defibrillator (ICD) shocks.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Inability or physical contraindication to perform physical exercise at the time of inclusion.
- Presence of overlapping phenotypes associated with other non-arrhythmogenic cardiomyopathies.
- Active pregnancy.
- Current engagement in competitive or high-intensity sports or exercise programs at the time of inclusion.
About this study
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)
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.
Read the detailed description
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:
- Experimental Group: Participants will undergo a 12-week supervised cardiac rehabilitation program. This intervention involves individualized, moderate-intensity exercise sessions. The intensity of the exercise prescription will be titrated based on baseline cardiopulmonary exercise testing (CPET) and individual cardiovascular risk profiles, aiming to improve functional capacity while minimizing the risk of pro-arrhythmic events.
- Control Group: Participants will follow conventional standard-of-care recommendations, which emphasize physical activity restriction as per current clinical practice guidelines for high-risk ACM.
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:
- Biological Sex: Categorized as male or female.
- Causal Genotype: Categorized by the identified pathogenic variant (LMNA, DSP, FLNC, TMEM43, PLN, or DES).
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.
- Being tested
- Cardiac Rehabilitation Programme
- Medical subject headings
- Arrhythmogenic Right Ventricular Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation ProgrammeBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation Program | Experimental | 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). Receives: Behavioral: Cardiac Rehabilitation Programme |
| Standard Physical Restriction | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline up to 6 months.
Secondary outcomes (13)
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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: Baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmogenic Cardiomyopathy (AC, ARVD/C)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Jiménez Jáimez
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Responsible party
- Sponsor-investigator, Juan Jiménez Jáimez, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708311
- Sponsor's protocol ID
- HGEN-CARE-AC STUDY
- Acronym
- HGEN-CARE-AC
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07708311
- Acronym / sponsor ID
- HGEN-CARE-AC / HGEN-CARE-AC STUDY
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Juan Jiménez JáimezUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Experimental Group: Participants will undergo a 12-week supervised cardiac rehabilitation program. This intervention involves individualized, moderate-intensity exercise sessions. The intensity of the exercise prescription will be titrated based on baseline cardiopulmonary exercise testing (CPET) and individual cardiovascular risk profiles, aiming to improve functional capacity while minimizing the risk of pro-arrhythmic events.
- Control Group: Participants will follow conventional standard-of-care recommendations, which emphasize physical activity restriction as per current clinical practice guidelines for high-risk ACM.
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:
- Biological Sex: Categorized as male or female.
- Causal Genotype: Categorized by the identified pathogenic variant (LMNA, DSP, FLNC, TMEM43, PLN, or DES).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation Program | Experimental | Behavioral: Cardiac Rehabilitation ProgrammeParticipants 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). |
| Standard Physical Restriction | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be 18 years of age or older at the time of signing the informed consent.
- Definite diagnosis of arrhythmogenic cardiomyopathy (ACM) according to the 2024 European Task Force criteria.
- Documented left or right ventricular involvement confirmed via transthoracic echocardiography or cardiac magnetic resonance imaging (MRI), characterized by abnormalities in regional contractility, presence of aneurysms, reduced ejection fraction, and/or late gadolinium enhancement (LGE).
- Confirmed presence of a pathogenic or likely pathogenic genetic variant in the LMNA, DSP, FLNC, TMEM43, PLN, or DES genes.
- Clinical stability maintained for 3 months or longer prior to inclusion, defined as the absence of hospital admissions, sustained ventricular arrhythmic events, or implantable cardioverter-defibrillator (ICD) shocks.
Key exclusion criteria (4 listed)
- Inability or physical contraindication to perform physical exercise at the time of inclusion.
- Presence of overlapping phenotypes associated with other non-arrhythmogenic cardiomyopathies.
- Active pregnancy.
- Current engagement in competitive or high-intensity sports or exercise programs at the time of inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Rehabilitation ProgrammeA 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 | Behavioural | Cardiac Rehabilitation Program |
Primary outcome
Composite safety endpoint of clinical and arrhythmic events.
Time frame: From baseline up to 6 months.
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.
13 secondary outcomes
Change from baseline in peak oxygen consumption (VO2 peak)
Time frame: Baseline and 12 weeks
Change from baseline in metabolic equivalents (METs)
Time frame: Baseline and 12 weeks
Change from baseline in 6-minute walk distance
Time frame: Baseline and 12 weeks.
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
Time frame: Baseline and 6 months.
Change from baseline in SF-36 health-related quality of life score
Time frame: Baseline and 6 months.
Change from baseline in EQ-5D-5L index score
Time frame: Baseline and 6 months.
Change in left ventricular ejection fraction (LVEF)
Time frame: Baseline and 6 months.
Change in right ventricular ejection fraction (RVEF)
Time frame: Time Frame: Baseline and 6 months.
Change in left ventricular internal diameter
Time frame: Baseline and 6 months.
Change from baseline in Body Mass Index (BMI)
Time frame: Baseline and 12 weeks.
Change from baseline in systolic blood pressure
Time frame: Baseline and 12 weeks.
Change from baseline in serum LDL cholesterol
Time frame: Baseline and 12 weeks.
Change from baseline in glycated hemoglobin (HbA1c)
Time frame: Baseline and 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation Programme in people with Arrhythmogenic Cardiomyopathy (AC, ARVD/C), run by Juan Jiménez Jáimez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite safety endpoint of clinical and arrhythmic events. (time frame: From baseline up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.