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Arrhythmogenic Activity During Exercise in ARVC Patients

Primary Purpose

Arrhythmogenic Right Ventricular Cardiomyopathy

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exercise
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrhythmogenic Right Ventricular Cardiomyopathy focused on measuring exercise, cycling, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients Group

Arm Description

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

Outcomes

Primary Outcome Measures

count of premature ventricular beats during and after the activities
count of premature ventricular beats during and after the activities

Secondary Outcome Measures

cardiac load during different activities, as rate-pressure product
product of heart rate and systolic blood pressure
cardiac load during different activities, as cardiac output
product of heart rate and stroke volume, in L/min
cardiac load during different activities, as peak blood pressure
systolic blood pressure, in mmHg

Full Information

First Posted
September 8, 2023
Last Updated
September 15, 2023
Sponsor
Swiss Federal Institute of Technology
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT06040242
Brief Title
Arrhythmogenic Activity During Exercise in ARVC Patients
Official Title
Characterization of Arrhythmogenic Activity During and After Physical Exercise in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmogenic Right Ventricular Cardiomyopathy
Keywords
exercise, cycling, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients Group
Arm Type
Experimental
Arm Description
All patients will perform all exercises. Arrhythmogenic activity will compared with that assessed during treadmill walking.
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
cycling, squats, biceps curls, walking
Intervention Description
Participants will perform 3 min of the different activities, followed by a 10-min recovery window.
Primary Outcome Measure Information:
Title
count of premature ventricular beats during and after the activities
Description
count of premature ventricular beats during and after the activities
Time Frame
measured during the 3 min of activity and the 10 min of recovery
Secondary Outcome Measure Information:
Title
cardiac load during different activities, as rate-pressure product
Description
product of heart rate and systolic blood pressure
Time Frame
measured during the 3 min of activity
Title
cardiac load during different activities, as cardiac output
Description
product of heart rate and stroke volume, in L/min
Time Frame
measured during the 3 min of activity
Title
cardiac load during different activities, as peak blood pressure
Description
systolic blood pressure, in mmHg
Time Frame
measured during the 3 min of activity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando G Beltrami, PhD
Phone
+41446330472
Email
fernando.beltrami@hest.ethz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Christina M Spengler, PhD, MD
Phone
+41446355007
Email
spengler@ethz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina M Spengler, PhD, MD
Organizational Affiliation
ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
City
Zurich
State/Province
ZH
ZIP/Postal Code
8057
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando G Beltrami, PhD
Email
fernando.beltrami@hest.ethz.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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Arrhythmogenic Activity During Exercise in ARVC Patients

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