Home-based Cardiovascular Rehabilitation in Young Patients With Congenital Heart Disease: the "Mu… (NCT07115589) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Home-based Cardiovascular Rehabilitation in Young Patients With Congenital Heart Disease: the "Muscle Your Heart" Program
France21 participantsStarted 2026-01-01
Plain-language summary
Standard cardiovascular rehabilitation is performed in a medical care and rehabilitation centre. However, it may not be adapted to the patient's profile and there are few medical care and rehabilitation centres specialized in pediatric cardiology. The objective of this study is to evaluate the impact of cardiovascular rehabilitation entirely at home on the physical fitness of young patients with congenital heart disease.
Who can participate
Age range
8 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Indication for home cardiovascular rehabilitation given by the referring cardiologist as part of routine care.
* Follow-up for congenital heart disease in the ACC-CHD classification.
* Patient aged 8 to 25 years at the time of inclusion.
* Consent of the adult patient or the parents or legal guardians of the minor patient.
* Social security affiliation (excluding AME).
* VO2max and/or SV1 \< -1.64 z-score for patients aged 8 to 17 years or VO2max \< 80% and/or SV1 \< 55% of theoretical VO2max for patients aged 18 to 25 years
Exclusion Criteria:
* Unstable and/or severe heart failure: severe heart failure (NYHA functional class IV), recent decompensated heart failure requiring hospitalisation and/or any significant change in medication (\< 3 months before inclusion), systolic ventricle dysfunction (left ventricular or systemic ventricular ejection fraction \< 50%).
* Severe hypoxemia: pulse oxygen saturation (SpO2) at rest \< 85%, and/or SpO2 at exercise \< 80%, and/or patient requiring oxygen therapy.
* Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology.
* Significant systolic right ventricle (sRV) hypertension (Srv pressure \> 50% of systemic systolic pressure).
* Uncontrolled arrhythmia: symptomatic arrhythmia treated or untreated at rest and/or during exercise, treated arrhythmia with sustained supraventricular or ventricular tachycardia on ECG monitoring or during exercise and/or CPET, occurrence or aggravation of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evolution of the maximal oxygen consumption (VO2max) obtained in the cardiopulmonary exercise test (CPET)
Timeframe: baseline and at the end of the 3-month program (week 12)