Arrhythmogenic Activity During Exercise in ARVC Patients

NCT ID: NCT06040242

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-08-31

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.

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 squats while undergoing extensive cardiovascular monitoring.

Conditions

Arrhythmogenic Right Ventricular Cardiomyopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients Group

All patients will perform all exercises. Arrhythmogenic activity will compared with that assessed during treadmill walking.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Participants will perform 3 min of the different activities, followed by a 10-min recovery window.

Interventions

Exercise

Participants will perform 3 min of the different activities, followed by a 10-min recovery window.

Intervention Type: OTHER

Other Intervention Names

cycling, squats, biceps curls, walking

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)
• 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina M Spengler, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport

Locations

Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Fernando G Beltrami, PhD

Role: CONTACT

fernando.beltrami@hest.ethz.ch

+41446330472

Christina M Spengler, PhD, MD

Role: CONTACT

spengler@ethz.ch

+41446325007

Facility Contacts

Fernando G Beltrami, PhD

Role: primary

fernando.beltrami@hest.ethz.ch

Other Identifiers

EAP_2020

Identifier Type: -

Identifier Source: org_study_id