NCT04036799
Active, not recruiting
Not Applicable
Development of a Risk Calculator to Predict Sudden Cardiac Death in Children With Hypertrophic Cardiomyopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertrophic Cardiomyopathy
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 572
- Primary Endpoint
- Number of Participants With a Composite Sudden Cardiac Death Event
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
This is a retrospective cohort study of pediatric hypertrophic cardiomyopathy (HCM) patients using chart and registry review methodology. The studies objective is to develop and validate a sudden cardiac death (SCD) risk calculator that is age-appropriate for children with HCM that includes clinical and genetic factors.
Investigators
Seema Mital
Principal Investigator
The Hospital for Sick Children
Eligibility Criteria
Inclusion Criteria
- •phenotype-positive patients diagnosed with hypertrophic cardiomyopathy
- •phenotype-negative, genotype positive patients considered at risk for developing hypertrophic cardiomyopathy
Exclusion Criteria
- •Neuromuscular, metabolic, syndromic (other than Noonan Syndrome and related RAS-opathies) or endocrine (including infants of diabetic mothers) causes of HCM
- •(Other treatable causes of left ventricular hypertrophy (systemic hypertension, anatomic defects causing left ventricular outflow tract obstruction e.g. aortic stenosis, subAS, subaortic membrane, coarctation)
Outcomes
Primary Outcomes
Number of Participants With a Composite Sudden Cardiac Death Event
Time Frame: Time to a composite sudden cardiac death event during 5-year follow-up
The composite SCD event includes post diagnosis SCD, aborted SCD (including ventricular fibrillation, sustained ventricular tachycardia), primary ICD insertion with appropriate shock, secondary ICD insertion
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