Clinical trial NCT06256913: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Confirmed sarcomeric hypertrophic cardiomyopathy population

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular mortality (composite)
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Hospitalisation for cardiovascular event (composite)
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Worsening of NYHA stage (composite)
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Onset of ventricular arrhythmia (composite)
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Onset of supra ventricular arrhythmia (composite)
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (composite)
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Secondary outcomes:
measure: Onset of tachycardia and or atrial fibrillation
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Sudden death, recovered or not recovered
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Cardiac decompensation requiring IV diuretics intake
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Occurrence of atrial fibrillation, atrial tachycardia or atrial flutter
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Cardiac remodelling
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Cardiac remodelling
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
measure: Cardiac remodelling
timeFrame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Boredeaux Hôpital Cardiologique du Haut-Lévêque
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: CHRU de Nancy
name: Nicolas Girerd, MD
role: STUDY_CHAIR
References: