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

NCT06256913 | Recruiting

• 1 other identifier: 2022PI172
• Study Type: observational
• Target: 870
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• Cardiac remodelling

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Confirmed sarcomeric hypertrophic cardiomyopathy population

You may qualify if:

• Age \>18
• Patients with confirmed sarcomeric hypertrophic cardiomyopathy

You may not qualify if:

• 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

Sponsors & Collaborators

• Pr. Nicolas GIRERD: lead

Study Sites (2)

CHU de Boredeaux Hôpital Cardiologique du Haut-Lévêque

Bordeaux, France

RECRUITING

CHRU de Nancy

Nancy, France

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Nicolas Girerd, MD

  CHRU de Nancy

  STUDY CHAIR

Central Study Contacts

Olivier Huttin, MD, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 13, 2024
• Study Start: May 6, 2023
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

FR (2)