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Observational Study of AAV9 Antibodies and ARVC Progression

This study is looking at people aged 14 to 65 with a specific heart condition called Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) caused by a change in the PKP2 gene. Researchers want to understand how this condition naturally progresses over time and to see how many patients already have antibodies (immune system defenses) against something called AAV9. AAV9 is a common virus that is sometimes used in gene therapies. You would receive your usual medical care, and researchers would collect biological samples annually to check heart-related markers. They will also collect clinical information for up to 5 years and ask you to complete quality of life questionnaires. This is an observational study, meaning no new treatments are given, and your participation is valuable whether or not you are interested in gene therapy.

Study design
This is a multicenter, observational study planning to enroll 200 participants. It is not testing a new intervention but rather observing the natural course of the disease.
What's involved
You would receive standard medical care. Biological samples would be collected annually, and clinical data would be gathered for up to 5 years. You may also complete quality of life questionnaires and have annual Holter monitoring if not part of your usual care.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years from the date of enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06311708

Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Recruiting
Not specifiedAges 14–65Observational
Tenaya Therapeutics
~200 participants
Updated 2024-11-01 on ClinicalTrials.gov

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Investigate the seroprevalence of pre-existing antibodies to AAV9 in patients with PKP2-associated ARVC
Measured over 5 years

Conditions

Arrhythmogenic Right Ventricular Cardiomyopathy

Explore related trials

Arrhythmogenic Right Ventricular DysplasiaPKP2 Gene

Where it's being run

21 sites across 13 states
France4
United Kingdom4
Germany2
Italy2
California1
Colorado1
Maryland1
Massachusetts1

Who to contact

Matthew Pollman, MD
[email protected]
650-209-8092
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ages 14-65 years, inclusive, at the time of consent
Pathogenic or likely pathogenic PKP2 gene mutation
Diagnosed with ARVC and meet 2010 Modified Task Force Criteria for ARVC as affected.
Functioning ICD

Exclusion

Currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy, immunoglobulin therapy or monoclonal antibody therapy
History of clinically significant liver disease, hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or tuberculosis infection
Previously dosed with any investigational or approved gene therapy product at any time
Concurrent participation in another interventional clinical trial unless approved by the Sponsor. Participation in a noninterventional study may be allowed at the investigator's discretion.
History of cardiac transplant.

What this trial measures

  • Investigate the seroprevalence of pre-existing antibodies to AAV9 in patients with PKP2-associated ARVC5 years