Arrhythmogenic Activity During Exercise in ARVC Patients

NCT06040242 | Recruiting DMC

• 1 other identifier: EAP_2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmogenic Right Ventricular Cardiomyopathy

Keywords

exercise; cycling; physical activity

Outcome Measures

Primary Outcomes (1)

• count of premature ventricular beats during and after the activities

  count of premature ventricular beats during and after the activities

  measured during the 3 min of activity and the 10 min of recovery

Secondary Outcomes (3)

• cardiac load during different activities, as rate-pressure product

  measured during the 3 min of activity

• cardiac load during different activities, as cardiac output

  measured during the 3 min of activity

• cardiac load during different activities, as peak blood pressure

  measured during the 3 min of activity

Study Arms (1)

Patients Group

EXPERIMENTAL

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

Other: Exercise

Interventions

Exercise OTHER

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

Also known as: cycling, squats, biceps curls, walking

Patients Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• University of Zurich: collaborator

Study Sites (1)

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

Zurich, Canton of Zurich, 8092, Switzerland

RECRUITING

MeSH Terms

Conditions

Arrhythmogenic Right Ventricular Dysplasia; Motor Activity

Interventions

Exercise; Walking

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Cardiomyopathies; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Locomotion

Study Officials

• Christina M Spengler, PhD, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando G Beltrami, PhD

CONTACT

+41446330472; fernando.beltrami@hest.ethz.ch

Christina M Spengler, PhD, MD

CONTACT

+41446325007; spengler@ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)