Status:
RECRUITING
Arrhythmogenic Activity During Exercise in ARVC Patients
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
University of Zurich
Conditions:
Arrhythmogenic Right Ventricular Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Current guidelines advocate that ARVC patients, typically young and active individuals with a significant history of competitive endurance sports, cease endurance training in favour of activities with...
Detailed Description
In this study, ARVC patients with different genotypes will perform a series of different physical activities, including treadmill walking, cycling at different intensities, biceps curls and loaded squ...
Eligibility Criteria
Inclusion
- Definitive ARVC diagnosis according to the modified 2010 ARVC Task Force Criteria
- Pathogenic / likely pathogenic variant in one of the following desmosomal genes: plakophilin-2 (PKP-2), desmoglein-2 (DSG-2) or desmoplakin (DSP) or gene-elusive definite ARVC (i.e., genetic test performed but no pathogenic / likely pathogenic variant found)
- Agreement with responsible primary cardiologist that study participation is not considered beyond acceptable levels of physical activity for this particular patient
- No history of exercise-induced syncope in the 6 months prior to study participation
- No history of sudden cardiac arrest in the 6 months prior to study participation
- In patients who suffered from sudden cardiac arrest/arrhythmic syncope, only those having an implantable cardioverter-defibrillator (ICD) and being under beta-blockers/antiarrhythmic drugs are eligible for study inclusion
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age: \> 18 years
- Body-Mass-Index (BMI): 18.5 - 29.9 kg･m-2
- Willing to adhere to the following study rules:
- No intense exercise 48h prior to testing
- No exercise 24h prior to testing
- Sleep at least 7h the two nights before testing On test day
- No caffeinated food or drink before testing on test day
- No alcohol before testing on test day
- Fully compliant with normal medication regimen including beta-blockers and antiarrhythmic medication
Exclusion
- No genetic test history for ARVC variants
- Heart failure with severely reduced left ventricular ejection fraction (LVEF \<35%)
- For women: Pregnancy, breastfeeding, or intention to become pregnant during the study.
- Known or suspected non-compliance, drug, or alcohol abuse
- Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06040242
Start Date
August 1 2023
End Date
August 31 2025
Last Update
May 18 2025
Active Locations (1)
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1
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
Zurich, Canton of Zurich, Switzerland, 8092