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OpenTrials
Active, Not Recruiting

NCT Number: NCT04036799

PRecIsion Medicine in CardiomyopathY

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • 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 British Columbia
  • Royal Children's Hospital
  • Stanford University
  • Stollery Children's Hospital
  • The Cleveland Clinic
  • University of Michigan
  • University of Texas Southwestern Medical Center

Registry information

Official study title

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

Acronym: PRIMaCY

Important dates

Study start
2017
Primary completion
2020
Study completion
2026
First posted
Jul 30, 2019
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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