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

Hypertrophic Cardiomyopathy Clinical Trial

— 2022PI172  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06256913
• Other study ID #: 2022PI172
• Status: Recruiting
• Start date: May 6, 2023
• Est. completion date: May 6, 2024

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Olivier Huttin, MD, PhD
• Phone: + 33 3 83 15 73 55
• Email: o.huttin[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 870
• Est. completion date: May 6, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Locations

Country	Name	City	State
France	CHU de Boredeaux Hôpital Cardiologique du Haut-Lévêque	Bordeaux
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Pr. Nicolas GIRERD

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Primary	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)	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Primary	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)	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Primary	Onset of ventricular arrhythmia (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, 2,3, 5,6)	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Primary	Onset of supra ventricular arrhythmia (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, 2,3,4,6)	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Primary	Onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (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 1,2,3,4,5)	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Secondary	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)	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Secondary	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)	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Secondary	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)	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Secondary	Occurrence of atrial fibrillation, atrial tachycardia or atrial flutter	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)	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Secondary	Cardiac remodelling	Evaluated by measurement of left ventricular mass as well as the appearance of late enhancement on MRI.	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Secondary	Cardiac remodelling	Evaluated by measurement of volume as well as the appearance of late enhancement on MRI.	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Secondary	Cardiac remodelling	Evaluated by measurement of function as well as the appearance of late enhancement on MRI.	From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)