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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Sudden death, recovered or not recovered |
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Inclusion Criteria:
Exclusion Criteria:
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Confirmed sarcomeric hypertrophic cardiomyopathy population
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier Huttin, MD, PhD | Contact | + 33 3 83 15 73 55 | o.huttin@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Girerd, MD | CHRU de Nancy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Boredeaux Hôpital Cardiologique du Haut-Lévêque | Recruiting | Bordeaux | France |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| 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) |
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 | 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 | 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 | 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 | 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 | 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) |
| CHRU de Nancy | Recruiting | Nancy | France |
|
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |