Diabetes Clinical Trial
— METAB-HEARTOfficial title:
Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype
"Little is known about the prevalence, determinants and phenotypes of the cardiomyopathy associated with diabetes and/or metabolic syndrome. The emergence of new therapies (SGLT2 inhibitors) that may mitigate and even prevent the onset of heart failure offers new opportunities.The objective of this protocol is to evaluate the prevalence and phenotypes of cardiomyopathy confirmed by echography in people at high metabolic risk defined as living with diabetes or obesity."
Status | Not yet recruiting |
Enrollment | 1500 |
Est. completion date | September 14, 2023 |
Est. primary completion date | July 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Adults (18 years-old or more) - At high metabolic risk: diabetes of any type and/or obesity (body mass index = 30 kg/m²) - Admission in the departement of Diabetology-Obesity-Nutrition, Avicenne Hospital, Bobigny, France - Patient informed and having signed consent - Patient affiliated to a social security scheme or entitled Exclusion Criteria: - Any know cardiac disease: coronary artery disease, heart failure, cardiomyopathy, pulmonary embolism < 6 months, pulmonary hypertension, rhythm disorders < 6 months - Blood pressure > 180/110 mmHg - Severe renal failure as defined by estimated glomerular filtration rate < 30 ml/min - Age = 80 years - Previous inclusion in the study - Patient under guardianship curatorship - Patient on AME (aide médicale d'état) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Echographic cardiomyopathy | Echographic cardiomyopathy defined as:
Reduced left ventricular ejection fraction (LVEF)<50%, and/or Abnormal diastolic function defined as more than half of positive criteria among: E/e'>14, septal e' velocity<7cm/s or lateral e' velocity<10cm/s, Tricuspid regurgitation (TR) velocity>2.8m/s, indexed left atrial (LA) volume>34ml/m², and/or Isolated left ventricular hypertrophy defined as LV mass =115g/m² in male and =95g/m² in female Reduced contractility as defined by global longitudinal strain (GLS) < 20%, and/or If clinical sign & symptom, resting ECG and biomarkers are normal, then echography will not be carried out and the cardiomyopathy will be considered absent. " |
18 months |
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