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Recruiting NCT04303364

CARdiomyopathy in Type 2 DIAbetes Mellitus

Trial Parameters

Condition Cardiomyopathy, Diabetic
Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,600
Sex ALL
Min Age 40 Years
Max Age 80 Years
Start Date 2020-10-02
Completion 2028-04-01

Brief Summary

The objective of the CARDIATEAM clinical study is to assess the uniqueness of diabetic cardiomyopathy (DCM) relative to other forms of cardiomyopathy using unsupervised clustering approaches based on deep phenotyping (clinical, imaging and biological) information.

Eligibility Criteria

Inclusion criteria * Female or male, aged between ≥ 40 and ≤80 years * Normal LVEF AND absence of akinetic segment assessed by echocardiography (i.e. LVEF≥50%) * Patients diagnosed according to the specific diagnostic criteria of each disease (Cf. table below (definition criteria)). For each group, the diagnosis will be based on current accepted criteria: * HFpEF: left ventricular ejection fraction (LVEF) LVEF≥50% AND presence/or history of symptoms (e.g. breathlessness, ankle swelling and fatigue) or signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral oedema) of heart failure AND significant diastolic dysfunction (left atrial volume index \>34 mL/m2 or a LVMI ≥115 g/m2 for males and ≥95 g/m2 for female, E/e' ≥13 and e' \<9 cm/s) OR NT-proBNP \>125 pg/Ml * No HFpEF: LVEF≥50% AND absence of symptoms (e.g. breathlessness, ankle swelling and fatigue) or signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral oedema) of heart failure * T2

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