PRecIsion Medicine in CardiomyopathY

N/AActive Not RecruitingNCT04036799

The Hospital for Sick Children572 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

572

Conditions

Hypertrophic Cardiomyopathy Sudden Cardiac Death

Eligibility

Sex: ALLMin age: 0 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

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

Time frame: Time to a composite sudden cardiac death event during 5-year follow-up

Data from ClinicalTrials.gov

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