Can we tell diabetic heart disease apart from other heart conditions?
NCT ID NCT04303364
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at over 1,200 adults with type 2 diabetes and heart muscle problems to see if diabetic cardiomyopathy is a unique condition. Researchers will use detailed medical tests, imaging, and biological data to find patterns. The goal is to better understand and diagnose this type of heart disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better ways to diagnose and distinguish diabetic cardiomyopathy from other heart diseases.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly change patient care, and results may take years to apply.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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1,256 people
The number who actually took part.
- Started
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Oct 2020
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Since CARDIATEAM aims to assess the uniqueness of DCM, it will include a group of non-diabetic non-HFpEF individuals with diversified characteristics relating to obesity, glucose intolerance and hypertension. Consequently, CARDIATEAM cohort will recruit both non-diabetic and diabetic patients with a large spectrum of demographic, metabolic and cardiac (heart failure vs. no heart failure) clinical data.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Academisch ziekenhuis Maastricht, Cardiology
Maastricht, Netherlands
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Amsterdam UMC
Amsterdam, 1100 DD, Netherlands
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Cardiology Outpatient Department at Hôpital Henri Mondor.
Créteil, France
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Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38043, France
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Diabetology departement, Lariboisière Hospital
Paris, 75475, France
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Diabetology department, Cochin Institute
Paris, 75015, France
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Hopital Louis Pradel
Bron, 69677, France
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Hospital Gregorio Marañón
Madrid, 28007, Spain
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Hospital Vall Hebrón
Barcelona, 08035, Spain
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Hôpital CHU- Nantes
Nantes, 44093, France
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Institut D'Investigacions Biomedica August Pi I Sunyer (IDIBAPS)
Barcelona, Spain
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UMC Utrecht, Cardiology (DHL)
Utrecht, Netherlands
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University Hospital Aachen
Aachen, 52074, Germany
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University Hospital Heidelberg
Heidelberg, Germany
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University Medical Center Groningen (UMCG), Cardiology/Cardio Research
Groningen, Netherlands
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University of Dundee, Div of Molecular&Clinical Medicine
Dundee, DD1 9SY, United Kingdom
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department of diabetology and nutrition, APHM
Marseille, France
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