PRecIsion Medicine in CardiomyopathY
Active, not recruiting
- Conditions
- Hypertrophic CardiomyopathySudden Cardiac Death
- Registration Number
- NCT04036799
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 572
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With a Composite Sudden Cardiac Death Event 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
- Secondary Outcome Measures
Name Time Method