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Studies

Observational Recruiting

NCT06256913 on ClinicalTrials.gov

Machine Learning Approach Based on Echocardiographic Data to Improve Prediction of Cardiovascular Events in Hypertrophic Cardiomyopathy

Official title: Phénogroupage basé Sur l'Apprentissage Automatique Dans la Cardiomyopathie Hypertrophique Pour Identifier Les Facteurs prédictifs de la Fibrose Myocardique et Les événements Cardiovasculaires

  • Sponsor: Pr. Nicolas GIRERD
  • Enrollment: 870 (Estimated)
  • Study start: 2023-05-06 (Actual)
  • Primary completion: 2024-05-06 (Estimated)
  • Study completion: 2024-05-06 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

Hypertrophic cardiomyopathy is a pathology with a highly variable course, ranging from patients who are asymptomatic throughout their lives to those who experience sudden death and/or terminal heart failure.

The main objective is to develop and validate an algorithm (constructed through supervised learning) using cardiac imaging data to predict the risk of cardiovascular events in sarcomeric hypertrophic cardiomyopathy.

Conditions

  • Hypertrophic Cardiomyopathy

Primary Outcome Measures

  • Cardiovascular mortality (composite) (From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
    Rates of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 2,3,4,5,6)
  • Hospitalisation for cardiovascular event (composite) (From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
    Rates of cardiovascular mortality, hospitalization for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,3,4,5,6)
  • Worsening of NYHA stage (composite) (From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
    Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,2,4,5,6)
  • Onset of ventricular arrhythmia (composite) (From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
    Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1, 2,3, 5,6)
  • Onset of supra ventricular arrhythmia (composite) (From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
    Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1, 2,3,4,6)
  • Onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (composite) (From date of start of follow-up until death or loss to follow-up (up to 12 years of FU))
    Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,2,3,4,5)

Countries

France

Locations and Investigators

  • CHU de Boredeaux Hôpital Cardiologique du Haut-Lévêque, Bordeaux, France (Recruiting)
    • Patricia Reant, MD
  • CHRU de Nancy, Nancy, France (Recruiting)

Study Officials