Cardiomyopathy, DiabeticCARDIATEAMNCT04303364
CARdiomyopathy in Type 2 DIAbetes Mellitus
An observational study of Cardiomyopathy, Diabetic, run by Institut National de la Santé Et de la Recherche Médicale, France at 17 sites in 5 countries.
Trial 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 deep phenotyping (clinical, imaging and biological) information. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy, Diabetic
- How many people
- 1,256 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 2 Oct 2020to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 32Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
France7 sites
Hopital Louis Pradel
Bron, 69677
Cardiology Outpatient Department at Hôpital Henri Mondor.
Créteil
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38043
department of diabetology and nutrition, APHM
Marseille
Hôpital CHU- Nantes
Nantes, 44093
Diabetology department, Cochin Institute
Paris, 75015
Diabetology departement, Lariboisière Hospital
Paris, 75475
Netherlands4 sites
Amsterdam UMC
Amsterdam, 1100 DD
University Medical Center Groningen (UMCG), Cardiology/Cardio Research
Groningen
Academisch ziekenhuis Maastricht, Cardiology
Maastricht
UMC Utrecht, Cardiology (DHL)
Utrecht
Spain3 sites
Hospital Vall Hebrón
Barcelona, 08035
Institut D'Investigacions Biomedica August Pi I Sunyer (IDIBAPS)
Barcelona
Hospital Gregorio Marañón
Madrid, 28007
Germany2 sites
University Hospital Aachen
Aachen, 52074
University Hospital Heidelberg
Heidelberg
United Kingdom1 site
University of Dundee, Div of Molecular&Clinical Medicine
Dundee, DD1 9SY
About this study
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.
Read the 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 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
- Conditions
- Cardiomyopathy, Diabetic
- Keywords
- Type2 Diabetes Mellitus, Heart Failure with preserved ejection fraction
- Medical subject headings
- Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects without T2DM and without HF | Not described | |
| Patients without T2DM and with HFpEF | Not described | |
| Patients with T2DM and without HFpEF | Not described | |
| Patients with T2DM and HFpEF | Not described | |
| Patients without T2DM and with hypertrophic cardiomyopathy | Not described | |
| Patients with T2DM and with hypertrophic cardiomyopathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the uniqueness of diabetic cardiomyopathy (DCM) relative to other forms of cardiomyopathy
Use of unsupervised clustering approaches based on deep phenotyping (clinical, imaging and biological) information
Measured: 3 years
Secondary outcomes (3)
Identify the best clinical, biological, imaging and multi-OMICs predictors belonging to each identified cluster
Specific focus on cluster(s) relating to a putative diabetic cardiomyopathy comparatively to other clusters [diagnostic perspective]
Measured: 4 years
Assess prospective health outcomes (i.e. overall mortality, cardiovascular events and cardiac function) in the diabetic cardiomyopathy cluster identified
Compare them to those from the other clusters and pre-defined patient groups [prognostic perspective]
Measured: 5 years
Explore the pathophysiological and potentially causal pathways characterizing diabetic cardiomyopathy
Better understand the underlying mechanisms responsible for establishment and progression of disease, based on OMICs data and causal inference modeling
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start2 Oct 2020
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, DiabeticStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,256 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Responsible party
- Sponsor
- Investigators
- Geneviève DERUMEAUX, MD, PhD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303364
- Sponsor's protocol ID
- C19-10
- Acronym
- CARDIATEAM
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARdiomyopathy in Type 2 DIAbetes Mellitus
- ClinicalTrials.gov ID
- NCT04303364
- Acronym / sponsor ID
- CARDIATEAM / C19-10
- Conditions
- Cardiomyopathy, Diabetic
- Keywords
- Type2 Diabetes Mellitus, Heart Failure with preserved ejection fraction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,256 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Subjects without T2DM and without HF | – | – |
| Patients without T2DM and with HFpEF | – | – |
| Patients with T2DM and without HFpEF | – | – |
| Patients with T2DM and HFpEF | – | – |
| Patients without T2DM and with hypertrophic cardiomyopathy | – | – |
| Patients with T2DM and with hypertrophic cardiomyopathy | – | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (32 listed)
- 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:
- Suitable echocardiographic window
- Absence of history of coronary artery disease including history of myocardial ischaemia, myocardial infarction or percutaneous coronary intervention
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the uniqueness of diabetic cardiomyopathy (DCM) relative to other forms of cardiomyopathy
Time frame: 3 years
Use of unsupervised clustering approaches based on deep phenotyping (clinical, imaging and biological) information
3 secondary outcomes
Identify the best clinical, biological, imaging and multi-OMICs predictors belonging to each identified cluster
Time frame: 4 years
Assess prospective health outcomes (i.e. overall mortality, cardiovascular events and cardiac function) in the diabetic cardiomyopathy cluster identified
Time frame: 5 years
Explore the pathophysiological and potentially causal pathways characterizing diabetic cardiomyopathy
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geneviève DERUMEAUX, MD, PhD principal investigator
Henri Mondor University Hospital
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, Diabetic, run by Institut National de la Santé Et de la Recherche Médicale, France at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Netherlands, Spain, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the uniqueness of diabetic cardiomyopathy (DCM) relative to other forms of cardiomyopathy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.