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NCT04303364Active, not recruiting

CARdiomyopathy in Type 2 DIAbetes Mellitus

Source: ClinicalTrials.gov · Last updated 6 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1256 (actual)
First submitted
6 Mar 2020
Start date
2 Oct 2020
Primary completion date
1 Apr 2028
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
NCT number
NCT04303364

What you commit to

  • Study type: Observational
  • Participants enrolled: 1256
  • From 2 Oct 2020 to the primary completion date, 1 Apr 2028
  • 17 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 40 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Aachen
Coordinator of this site? Confirm its status		AachenGermanyUnknown status
University Hospital Heidelberg
Coordinator of this site? Confirm its status		HeidelbergGermanyUnknown status
Institut D'Investigacions Biomedica August Pi I Sunyer (IDIBAPS)
Coordinator of this site? Confirm its status		BarcelonaSpainUnknown status
Hospital Vall Hebron
Coordinator of this site? Confirm its status		BarcelonaSpainUnknown status
Hospital Gregorio Marañon
Coordinator of this site? Confirm its status		MadridSpainUnknown status
Hôpital Louis Pradel
Coordinator of this site? Confirm its status		BronFranceUnknown status
Cardiology Outpatient Department at Hôpital Henri Mondor.
Coordinator of this site? Confirm its status		CréteilFranceUnknown status
Centre hospitalier universitaire Grenoble-Alpes
Coordinator of this site? Confirm its status		GrenobleFranceUnknown status
department of diabetology and nutrition, APHM
Coordinator of this site? Confirm its status		MarseilleFranceUnknown status
Hôpital CHU- Nantes
Coordinator of this site? Confirm its status		NantesFranceUnknown status
Diabetology departement, Lariboisière Hospital
Coordinator of this site? Confirm its status		ParisFranceUnknown status
Diabetology department, Cochin Institute
Coordinator of this site? Confirm its status		ParisFranceUnknown status
University of Dundee, Div of Molecular&Clinical Medicine
Coordinator of this site? Confirm its status		DundeeUnited KingdomUnknown status
Amsterdam UMC
Coordinator of this site? Confirm its status		AmsterdamNetherlandsUnknown status
University Medical Center Groningen (UMCG), Cardiology/Cardio Research
Coordinator of this site? Confirm its status		GroningenNetherlandsUnknown status
Academisch ziekenhuis Maastricht, Cardiology
Coordinator of this site? Confirm its status		MaastrichtNetherlandsUnknown status
UMC Utrecht, Cardiology (DHL)
Coordinator of this site? Confirm its status		UtrechtNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.