Haemodynamics and Ventricular Arrhythmias During Exercise in Patients With Arrhythmogenic Cardiom… (NCT06823271) | Clinical Trial Compass
CompletedNot Applicable
Haemodynamics and Ventricular Arrhythmias During Exercise in Patients With Arrhythmogenic Cardiomyopathy
Germany20 participantsStarted 2025-08-01
Plain-language summary
Patients with definitive and borderline arrhythmogenic cardiomyopathy (ACM) are usually recommended to refrain from high intensity exercise due to an increased risk of malignant arrhythmias. However, little is known about the effects of prolonged, low-to moderate endurance or resistance exercise on the burden of arrhythmias or central haemodynamics. This pilot interventional study assesses the impact of these modes of exercise on the electrophysiological substrate of the right ventricle (RV), measured by mapping of the RV, and central haemodynamics assessed by right heart catheterization. Patients older than 18 years of age with diagnosed borderline and definitive ACM are included with or without implantable cardioverter-defibrillator (ICD).
Who can participate
Age range
18 Years – 99 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:
* Age \>18 years of age
* Diagnosis of definitive or borderline arrhythmogenic cardiomyopathy (ACM) with or without implantable cardioverter defibrillator (ICD)
Exclusion Criteria:
* Age \<18 years of age
* Manifest acute heart failure
* Intracardiac shunts
* Pre-existing precapillary pulmonary hypertension
* Clinical suspicion of new coronary artery disease or disease progression
* More than grade II valvular heart disease at resting echocardiography
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
Difference of the ratio of mean pulmonary artery pressure and cardiac output (mPAP/CO) between rest and the exercise tests in a patient
Timeframe: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)