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New treatment option for Arrhythmogenic Right Ventricular Cardiomyopathy
Official title Arrhythmogenic Activity During Exercise in ARVC Patients
ClinicalTrials.gov ID: NCT06040242
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
- No history of exercise-induced syncope in the 6 months prior to study participation
You likely can't join 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
See the full eligibility 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...
- 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
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Canton of Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Canton of Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.