Hypertrophic Cardiomyopathy
Conditions
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.
Interventions
None listed
Sponsors
Pr. Nicolas GIRERD
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 left ventricular mass as well as the appearance of late enhancement on MRI. |
| 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) |
Countries
France
Contacts
Primary ContactOlivier Huttin, MD, PhD
Outcome results
None listed