Arrhythmogenic Right Ventricular CardiomyopathyNCT06040242
Arrhythmogenic Activity During Exercise in ARVC Patients
A study testing Exercise in people with Arrhythmogenic Right Ventricular Cardiomyopathy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrhythmogenic Right Ventricular Cardiomyopathy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
Zurich, Canton of Zurich, 8092
Fernando G Beltrami, PhD, fernando.beltrami@hest.ethz.ch
About this study
Official title: Characterization of Arrhythmogenic Activity During and After Physical Exercise in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
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.
Read the 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.
- Being tested
- Exercise
- Keywords
- exercise, cycling, physical activity
- Medical subject headings
- Arrhythmogenic Right Ventricular Dysplasia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called cycling, squats, biceps curls, walking
Participants will perform 3 min of the different activities, followed by a 10-min recovery window.
| Study group | Role | What they receive |
|---|---|---|
| Patients Group | Experimental | All patients will perform all exercises. Arrhythmogenic activity will compared with that assessed during treadmill walking. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
count of premature ventricular beats during and after the activities
count of premature ventricular beats during and after the activities
Measured: 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
product of heart rate and systolic blood pressure
Measured: measured during the 3 min of activity
cardiac load during different activities, as cardiac output
product of heart rate and stroke volume, in L/min
Measured: measured during the 3 min of activity
cardiac load during different activities, as peak blood pressure
systolic blood pressure, in mmHg
Measured: measured during the 3 min of activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmogenic Right Ventricular CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Christina M Spengler, PhD, MD, Principal investigator, ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040242
- Sponsor's protocol ID
- EAP_2020
- Status last verified
- Mar 2026
- First submitted
- 8 Sep 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Arrhythmogenic Activity During and After Physical Exercise in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
- ClinicalTrials.gov ID
- NCT06040242
- Acronym / sponsor ID
- EAP_2020
- Keywords
- exercise, cycling, physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Group | Experimental | Other: ExerciseAll patients will perform all exercises. Arrhythmogenic activity will compared with that assessed during treadmill walking. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: cycling, squats, biceps curls, walkingParticipants will perform 3 min of the different activities, followed by a 10-min recovery window. | Other | Patients Group |
Primary outcome
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
count of premature ventricular beats during and after the activities
3 secondary outcomes
cardiac load during different activities, as rate-pressure product
Time frame: measured during the 3 min of activity
cardiac load during different activities, as cardiac output
Time frame: measured during the 3 min of activity
cardiac load during different activities, as peak blood pressure
Time frame: measured during the 3 min of activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina M Spengler, PhD, MD principal investigator
ETH Zurich, Exercise Physiology Lab, Institute of Human Movement Sciences and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Arrhythmogenic Right Ventricular Cardiomyopathy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando G Beltrami, PhD (+41446330472, fernando.beltrami@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.