Machine Learning Approach Based on Echocardiographic Data to Improve Prediction of Cardiovascular Events in Hypertrophic Cardiomyopathy (2022PI172)

February 5, 2024 updated by: Pr. Nicolas GIRERD

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

870

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • CHU de Boredeaux Hôpital Cardiologique du Haut-Lévêque
        • Contact:
          • Patricia Reant, MD
      • Nancy, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Confirmed sarcomeric hypertrophic cardiomyopathy population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with sarcomeric hypertrophic cardiomyopathy and cardiovascular events
Patients with confirmed sarcomeric hypertrophic cardiomyopathy who experienced cardiovascular events.
Patients with sarcomeric hypertrophic cardiomyopathy free of cardiovascular events
Patients with confirmed sarcomeric hypertrophic cardiomyopathy free of cardiovascular events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality (composite)
Time Frame: 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)
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)
Time Frame: 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)
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)
Time Frame: 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)
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)
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)
Onset of supra 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)
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)
Onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (composite)
Time Frame: 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)
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of tachycardia and or atrial fibrillation
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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)
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)
Cardiac remodelling
Time Frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
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)
Cardiac remodelling
Time Frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
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)
Cardiac remodelling
Time Frame: 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.
From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pr. Nicolas GIRERD

Investigators

  • Study Chair: Nicolas Girerd, MD, CHRU de Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2023

Primary Completion (Estimated)

May 6, 2024

Study Completion (Estimated)

May 6, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI172

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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