Arrhythmogenic Activity During Exercise in ARVC Patients

Arrhythmogenic Right Ventricular Cardiomyopathy Clinical Trial

Official title:

Characterization of Arrhythmogenic Activity During and After Physical Exercise in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040242
• Other study ID #: EAP_2020
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Swiss Federal Institute of Technology
• Contact: Fernando G Beltrami, PhD
• Phone: +41446330472
• Email: fernando.beltrami[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmogenic Right Ventricular Cardiomyopathy
• Arrhythmogenic Right Ventricular Dysplasia
• Cardiomyopathies

Intervention

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

Locations

Country	Name	City	State
Switzerland	Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	cardiac load during different activities, as rate-pressure product	product of heart rate and systolic blood pressure	measured during the 3 min of activity
Secondary	cardiac load during different activities, as cardiac output	product of heart rate and stroke volume, in L/min	measured during the 3 min of activity
Secondary	cardiac load during different activities, as peak blood pressure	systolic blood pressure, in mmHg	measured during the 3 min of activity