PRecIsion Medicine in CardiomyopathY

Hypertrophic Cardiomyopathy Clinical Trial

— PRIMaCY  

Official title:

Development of a Risk Calculator to Predict Sudden Cardiac Death in Children With Hypertrophic Cardiomyopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04036799
• Other study ID #: 1000055819
• Status: Active, not recruiting
• Start date: January 1, 2017
• Est. completion date: December 2023

Study information

• Verified date: November 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 572
• Est. completion date: December 2023
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Death
• Death, Sudden, Cardiac
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Sudden Cardiac Death

Locations

Country	Name	City	State
n/a

Sponsors (20)

Lead Sponsor

Collaborator

The Hospital for Sick Children

Baylor College of Medicine, Children's Healthcare of Atlanta, Children's Hospital Colorado, Children's Hospital Los Angeles, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Eastern Ontario, Children's Hospital of Philadelphia, Indiana University Health, Monroe Carell Jr. Children's Hospital at Vanderbilt, New York Presbyterian Hospital, OHSU Doernbecher Children's Hospital, Primary Children's Hospital, Provincial Health Services Authority, Stanford University, Stollery Children's Hospital, The Cleveland Clinic, The Royal Children's Hospital Melbourne, University of Michigan, University of Texas Southwestern Medical Center

References & Publications (1)

Miron A, Lafreniere-Roula M, Steve Fan CP, Armstrong KR, Dragulescu A, Papaz T, Manlhiot C, Kaufman B, Butts RJ, Gardin L, Stephenson EA, Howard TS, Aziz PF, Balaji S, Ladouceur VB, Benson LN, Colan SD, Godown J, Henderson HT, Ingles J, Jeewa A, Jefferies — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 to a composite sudden cardiac death event during 5-year follow-up