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

Recruiting

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT06256913
• Lead Sponsor: Pr. Nicolas GIRERD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-06
• Study First Submitted: 2024-01-16
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-05
• Last Update Submitted: 2024-02-05
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-05-06
• Study Completion: 2024-05-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 870

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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)
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 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)

Secondary Outcome Measures

Name	Time	Method
Onset of tachycardia and or atrial fibrillation	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)	Tachycardia and/or ventricular fibrillation during follow-up as well as sudden death, recovered or not recovered. (With outcome 8)
Cardiac decompensation requiring IV diuretics intake	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)	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)
Sudden death, recovered or not recovered	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)	Tachycardia and/or ventricular fibrillation during follow-up as well as sudden death, recovered or not recovered. (With outcome 7)
Occurrence of atrial fibrillation, atrial tachycardia or atrial flutter	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)	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 9)
Cardiac remodelling	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)	Evaluated by measurement of function as well as the appearance of late enhancement on MRI.

Trial Locations

Locations (2)

CHU de Boredeaux Hôpital Cardiologique du Haut-Lévêque; 🇫🇷 Bordeaux, France

CHRU de Nancy; 🇫🇷 Nancy, France