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Can we tell diabetic heart disease apart from other heart conditions?

NCT ID NCT04303364

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

1,256 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

40 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Academisch ziekenhuis Maastricht, Cardiology

    Maastricht, Netherlands

  • Amsterdam UMC

    Amsterdam, 1100 DD, Netherlands

  • Cardiology Outpatient Department at Hôpital Henri Mondor.

    Créteil, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    Grenoble, 38043, France

  • Diabetology departement, Lariboisière Hospital

    Paris, 75475, France

  • Diabetology department, Cochin Institute

    Paris, 75015, France

  • Hopital Louis Pradel

    Bron, 69677, France

  • Hospital Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Vall Hebrón

    Barcelona, 08035, Spain

  • Hôpital CHU- Nantes

    Nantes, 44093, France

  • Institut D'Investigacions Biomedica August Pi I Sunyer (IDIBAPS)

    Barcelona, Spain

  • UMC Utrecht, Cardiology (DHL)

    Utrecht, Netherlands

  • University Hospital Aachen

    Aachen, 52074, Germany

  • University Hospital Heidelberg

    Heidelberg, Germany

  • University Medical Center Groningen (UMCG), Cardiology/Cardio Research

    Groningen, Netherlands

  • University of Dundee, Div of Molecular&Clinical Medicine

    Dundee, DD1 9SY, United Kingdom

  • department of diabetology and nutrition, APHM

    Marseille, France

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