NCT06040242 Arrhythmogenic Activity During Exercise in ARVC Patients
| NCT ID | NCT06040242 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Swiss Federal Institute of Technology |
| Condition | Arrhythmogenic Right Ventricular Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-08-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 low cardiac burden such as bowling and golf. Empirically, it is often suggested that heart rate during exercise should not exceed 100-120 bpm in these patients, but these guidelines are arbitrary and not scientifically based. In practice, it is estimated that up to 50% of patients do not comply with these recommendations . Adequate quantification of the arrhythmogenic burden, defined as premature ventricular beats in proportion to all heart beats in each period of time, and cardiac load (defined as stroke volume for volume load and systolic blood pressure for pressure load) experienced by ARVC patients when performing different types of physical exercise would be a first step towards designing a safe and effective intervention so that these patients can profit from an active life style. This study therefore aims to quantify and describe the arrhythmogenic burden and cardiac load experienced by patients with ARVC while performing different physical exercise over a range of intensities - all strictly within the range currently recommended by different cardiological societies.
Eligibility Criteria
Inclusion Criteria: * 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) * Control group: diagnosed ischemic heart disease with ejection fraction above 35% * 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: \> 14 years * Body-Mass-Index (BMI): 18.5 - 39.9 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 Criteria: * 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
Contact & Investigator
Christina M Spengler, PhD, MD
PRINCIPAL INVESTIGATOR
ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport
Frequently Asked Questions
Who can join the NCT06040242 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Arrhythmogenic Right Ventricular Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06040242 currently recruiting?
Yes, NCT06040242 is actively recruiting participants. Contact the research team at fernando.beltrami@hest.ethz.ch for enrollment information.
Where is the NCT06040242 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT06040242 clinical trial?
NCT06040242 is sponsored by Swiss Federal Institute of Technology. The principal investigator is Christina M Spengler, PhD, MD at ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport. The trial plans to enroll 120 participants.