CARdiomyopathy in Type 2 DIAbetes Mellitus
CARdiomyopathy in Type 2 DIAbetes Mellitus
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.
CARDIATEAM study will address the uniqueness of DCM, and its progression towards heart
 failure (HF) with preserved ejection fraction (HFpEF) by recruiting a prospective CARDIATEAM
 cohort (n=1600 individuals) from existing cohorts using a defined set of selection criteria
 and will include type2-Diabetes mellitus (T2DM)and non-diabetic patients with a large
 spectrum of demographic, metabolic and cardiac clinical data. This will yield a wide range of
 T2DM - related phenotypes including common confounders such as BMI, smoking, age and blood
 pressure.

 To clarify the phenotype of DCM and to differentiate it from the other forms of HF such as
 HFpEF or HCM, CARDIATEAM will perform unbiased clustering analysis from an in-depth
 phenotyping of these patients' populations
Inclusion Criteria:

 -  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. For
 each group, the diagnosis will be based on current accepted criteria:

 -  HFpEF: LVEF≥50% AND presence/or history of symptoms or signs of HF AND
 significant diastolic dysfunction OR NT-proBNP >125 pg/Ml

 -  NoHFpEF:LVEF≥50% AND absenceofsymptoms or signs of HF

 -  T2DM:HbA1c≥6.5% (≥48mmol/L)AND Fasting Plasma Glucose≥7.0mmol/L (≥126 mg/dL) or
 anti-diabetic treatment

 -  Normoglycemia defined as HbA1C <5.7% (39mmol/L) AND Fasting Plasma Glucose <5.6
 mmol/L (100mg/dL)

 -  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 window

 -  Absence of history of coronary artery disease including history of myocardial
 ischaemia, myocardial infarction or percutaneous coronary intervention

 -  Absence of significant coronary artery disease (CAD) defined as

 -  a negative stress test: stress echocardiography, myocardial perfusion
 scintigraphy or cardiac stress MRI performed within the 18 months before
 inclusion OR

 -  the absence of coronary stenosis ≥50% on a cardiac computed tomography (CT) or
 coronary angiography performed within the 18 months before inclusion

 -  Patient covered by a health insurance

 Exclusion Criteria:

 Diabetes mellitus other than type 2 (type 1, LADA, MODY, NODAT, etc.)

 -  Suboptimal echocardiographic window

 -  Significant valvular heart disease defined as severe aortic regurgitation or severe
 primary mitral regurgitation or aortic stenosis with a peak transvalvular velocity
 ≥3m/s or mitral stenosis with a mitral valve area < 1.5cm2

 -  Chronic atrial fibrillation or any significant arrhythmia at inclusion

 -  Renal insufficiency defined as eGFR<30 mL/min/1.73m2

 -  History of bariatric surgery

 -  Obstructive hypertrophic cardiomyopathy (definition: maximal gradient at rest <30mmHg)

 -  Hypertrophic cardiomyopathy due to a non-sarcomeric etiology

 -  Life threatening comorbidities (i.e. cancer, end-stage heart failure, severe lung
 disease, cirrhosis)

 -  Pregnancy

 -  Lactating mother

 -  Any condition which in the Investigator's opinion makes it undesirable for the subject
 to participate in the study or which would jeopardize compliance with the protocol

 -  Inability to understand the local language

 -  Individuals deprived of liberty

 -  Protected persons (under guardianship or curatorship)

 -  Contra-indication to CMR

 -  Known hypersensitivity to gadolinium based product