CARdiomyopathy in Type 2 DIAbetes Mellitus (NCT04303364) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CARdiomyopathy in Type 2 DIAbetes Mellitus
France1,256 participantsStarted 2020-10-02
Plain-language 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.
Who can participate
Age range40 Years – 80 Years
SexALL
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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
* T2DM: HbA1c ≥ 6.5% (≥ 48 mmol/L) AND Fasting Plasma Glucose ≥7.0 mmol/L (≥126 mg/dL) or anti-diabetic treatment
* Non T2DM: HbA1c \< 6.5% AND Fasting Plasma Glucose \<7.0 mmol/L without any anti-diabetic treatment including normoglycemic subjects
* HCM: patients with non-obstructive HCM of sarcomeric cause (proven with common genetic cause) and with LV wall thickness ≥ 15 mm in one or more myocardial segments in the absence of abnormal afterload conditions.
* Suitable echocardiographic…
What they're measuring
1
Assess the uniqueness of diabetic cardiomyopathy (DCM) relative to other forms of cardiomyopathy