Status:
ENROLLING_BY_INVITATION
Clinical Trial of the Sequence of Cardiovascular Genetic Counseling and Testing
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Human Genome Research Institute (NHGRI)
Conditions:
Genetic Counseling
Inherited Cardiac Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Although pre-test genetic counseling is widely recommended and has come to dominate genetic counseling practice, tailored results-focused genetic counseling could both increase genetic counseling effi...
Detailed Description
This is a three-arm randomized clinical trial with a parallel-group design comparing usual care (pre-test genetic counseling, test results by phone/electronic health record (EHR)) to two approaches to...
Eligibility Criteria
Inclusion
- Cardiovascular panel testing inclusion criteria:
- Adult (age 18+) scheduled for outpatient genetic counseling in the Johns Hopkins Center for Inherited Heart Diseases,
- Clinical diagnosis or suspected clinical diagnosis of a potentially inherited cardiovascular disease including a) hypertrophic, dilated, or arrhythmogenic cardiomyopathy, b) ventricular or atrial arrhythmias or an ECG-pattern suspicious for an inherited cardiovascular disease including catecholaminergic polymorphic ventricular tachycardia, long QT syndrome, or Brugada syndrome, or c) a diagnosed or suspected lipid disorder or early-onset coronary artery disease,
- next-generation cardiovascular sequencing panel clinically indicated.
- Family specific variant testing inclusion criteria:
- Adult (age 18+) scheduled for outpatient genetic counseling in the Johns Hopkins Center for Inherited Heart Diseases,
- Documented pathogenic or likely pathogenic variant in a gene associated with a hereditary cardiomyopathy, arrhythmia syndrome, or lipid disease in a family member,
- Referred to the Center for Inherited Heart Diseases for family-specific variant testing.
Exclusion
- Previous genetic counseling at Johns Hopkins for this clinical indication,
- Previous genetic testing that definitively identified the genetic cause of the patient's condition,
- Patient unable to speak or read English,
- Genetic counseling appointment is not anticipated to include genetic testing (for instance if it was scheduled to discuss family communication or adaptation to a new diagnosis),
- Next generation sequencing panel not clinically indicated (panel cohort only).
Key Trial Info
Start Date :
December 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT05422573
Start Date
December 20 2022
End Date
September 1 2026
Last Update
July 10 2025
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287