Status:
RECRUITING
CARdiomyopathy in Type 2 DIAbetes Mellitus
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Conditions:
Cardiomyopathy, Diabetic
Eligibility:
All Genders
40-80 years
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 ...
Detailed Description
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 indiv...
Eligibility Criteria
Inclusion
- 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 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:
- the absence of coronary artery stenosis ≥50% on a cardiac computed tomography (CT) OR a coronary angiography OR normal Fractional Flow Reserve (FFR \>0.80) OR
- Coronary Artery Calcium score (CAC) \<100 performed within the 48 months before inclusion
- Patient covered by a health insurance
- Non-inclusion 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 and candidate to bariatric surgery
- Obstructive hypertrophic cardiomyopathy (definition: maximal gradient at rest \<30 mmHg)
- Hypertrophic cardiomyopathy due to a non-sarcomeric etiology, i.e. known infiltrative or storage disorder mimicking HCM such as Fabry disease or amyloidosis
- Life threatening comorbidities (i.e. history of or active cancer treated with chemotherapy or radiotherapy, 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 (please see CMR-SOP):
- Known hypersensitivity to gadolinium based product (including gadoteric acid and meglumine)
- Known COVID-19 symptomatic infection requiring hospitalization
Exclusion
Key Trial Info
Start Date :
October 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT04303364
Start Date
October 2 2020
End Date
April 1 2028
Last Update
April 4 2025
Active Locations (17)
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1
Hopital Louis Pradel
Bron, France, 69677
2
Cardiology Outpatient Department at Hôpital Henri Mondor.
Créteil, France
3
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, France, 38043
4
department of diabetology and nutrition, APHM
Marseille, France