Could supervised exercise be safe for High-Risk heart patients?
NCT ID NCT07708311
First seen Jul 16, 2026 · Last updated Jul 21, 2026 · Updated 3 times
Summary
This trial investigates whether a structured, moderate-intensity cardiac rehabilitation program is safe for people with arrhythmogenic cardiomyopathy who carry high-risk genetic mutations. Participants will be randomly assigned to either the exercise program or standard physical restriction. The study aims to see if supervised exercise can improve fitness and quality of life without increasing dangerous heart rhythms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a supervised, moderate-intensity cardiac rehabilitation program
- What this could lead to
- If successful, this could provide a safe way for high-risk patients to exercise, improving their physical fitness and quality of life without triggering dangerous heart rhythms.
- What could go wrong
- This is an early exploratory trial with only 70 participants, so results may not apply to all patients. The exercise program could still increase arrhythmia risk in some individuals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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