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

Pr. Nicolas GIRERD870 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

870

Conditions

Hypertrophic Cardiomyopathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>18 * Patients with confirmed sarcomeric hypertrophic cardiomyopathy Exclusion Criteria: * Echocardiographic data not allowing deep analysis (technical default, bad echogenicity of the patient) * Other causes of left ventricular hypertrophy that may hamper the diagnosis (p.e. aortic or sub-aortic stenosis, severe renal insufficiency, hypertension). * History of ischemic heart disease or associated myocarditis * Opposition of the patient to the use of his/her data

Locations (2)

CHU de Boredeaux Hôpital Cardiologique du Haut-Lévêque

Bordeaux, France

RECRUITING

CHRU de Nancy

Nancy, France

RECRUITING

Outcomes

Primary Outcomes

Cardiovascular mortality (composite)

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)

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Hospitalisation for cardiovascular event (composite)

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)

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Worsening of NYHA stage (composite)

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)

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Onset of ventricular arrhythmia (composite)

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Onset of supra ventricular arrhythmia (composite)

Central Contacts

Olivier Huttin, MD, PhD

CONTACT

+ 33 3 83 15 73 55 o.huttin@chru-nancy.fr

Data from ClinicalTrials.gov

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Secondary Outcomes

Onset of tachycardia and or atrial fibrillation

Tachycardia and/or ventricular fibrillation during follow-up as well as sudden death, recovered or not recovered. (With outcome 8)

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Sudden death, recovered or not recovered

Tachycardia and/or ventricular fibrillation during follow-up as well as sudden death, recovered or not recovered. (With outcome 7)

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Cardiac decompensation requiring IV diuretics intake

Composite endpoint: cardiac decompensation requiring IV diuretics intake (managed in conventional hospitalization, day hospitalization or in-home) and the occurrence of atrial fibrillation, atrial tachycardia or atrial flutter. (With outcome 10)

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Occurrence of atrial fibrillation, atrial tachycardia or atrial flutter

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Cardiac remodelling

Evaluated by measurement of left ventricular mass as well as the appearance of late enhancement on MRI.

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Cardiac remodelling

Evaluated by measurement of volume as well as the appearance of late enhancement on MRI.

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Cardiac remodelling

Evaluated by measurement of function as well as the appearance of late enhancement on MRI.

Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)