Examining exercise effects on heart activity in ARVC patients
Characterization of Arrhythmogenic Activity During and After Physical Exercise in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
This study tests how different types of exercise affect heart activity in people with Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) to help create safer exercise guidelines for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Swiss Federal Institute of Technology Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT06040242 on ClinicalTrials.gov |
What this trial studies
This study investigates the arrhythmogenic activity in patients with Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) during various physical exercises. Participants will perform activities such as treadmill walking, cycling, and strength training while being closely monitored for cardiovascular responses. The aim is to quantify the arrhythmogenic burden and cardiac load experienced by these patients, which could inform safer exercise guidelines. By understanding how different exercises affect heart activity, the study seeks to develop effective interventions that allow ARVC patients to maintain an active lifestyle.
Who should consider this trial
Good fit: Ideal candidates include individuals with a definitive ARVC diagnosis and specific genetic variants, who have not experienced recent serious cardiac events.
Not a fit: Patients with a history of exercise-induced syncope or sudden cardiac arrest in the past six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized exercise recommendations that enhance the quality of life for ARVC patients.
How similar studies have performed: While there is limited research specifically on exercise in ARVC patients, similar studies in other cardiomyopathies have shown promising results in understanding exercise impacts on heart health.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zurich, Canton of Zurich
- Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christina M Spengler, PhD, MD — ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport
- Study coordinator: Fernando G Beltrami, PhD
- Email: fernando.beltrami@hest.ethz.ch
- Phone: +41446330472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.