| NCT ID | NCT03049254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Arrhythmogenic Right Ventricular Cardiomyopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2018-02-09 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2018-02-09 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very difficult as the disease process can be subtle, but sufficient enough, so that the first event is sudden death. The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from the US and UK. Family members who are blood-relatives will also be invited, including those who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI, Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples. Objectives of the study: 1. Discover new genes or altered genes (variants) which cause AVC 2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation) 3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, electrocardiographic and imaging data. 4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies
Eligibility Criteria
Inclusion Criteria: * Patients with a diagnosis of a non-MI SCA who survived * Patients with a non-MI SCD * Patient with a SCA associated with seizures, epilepsy, syncope, drowning and near-drowning, where a cardiomyopathy is suspected * Family member of a patient diagnosed with primary cardiomyopathy (including HCM, idiopathic DCM, AVC) Exclusion Criteria: * Patients with a clear, unambiguous known cause of SCA or SCD such as myocardial infarction or heart failure secondary to ischemic heart disease * Significant coronary artery disease (Epicardial coronary artery stenosis \>50%) which can explain degree of LV dysfunction * Those unwilling to provide written consent or assent
Contact & Investigator
Virend Somers, PhD, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT03049254 clinical trial?
This trial is open to participants of all sexes, studying Arrhythmogenic Right Ventricular Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03049254 currently recruiting?
Yes, NCT03049254 is actively recruiting participants. Contact the research team at wozniak.nicholas@mayo.edu for enrollment information.
Where is the NCT03049254 trial being conducted?
This trial is being conducted at Rochester, United States, Papworth Everard, United Kingdom.
Who is sponsoring the NCT03049254 clinical trial?
NCT03049254 is sponsored by Mayo Clinic. The principal investigator is Virend Somers, PhD, MD at Mayo Clinic. The trial plans to enroll 1,000 participants.