Clinical Trials in Spain / NCT04303364
Active, not recruiting
Observational
CARdiomyopathy in Type 2 DIAbetes Mellitus
NCT04303364 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Cardiomyopathy, Diabetic
Study 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.
Eligibility
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
Primary outcome measure(s)
- Assess the uniqueness of diabetic cardiomyopathy (DCM) relative to other forms of cardiomyopathy — 3 years
Use of unsupervised clustering approaches based on deep phenotyping (clinical, imaging and biological) information
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Hopital Louis Pradel | Bron | France | |
| Cardiology Outpatient Department at Hôpital Henri Mondor. | Créteil | France | |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble | France | |
| department of diabetology and nutrition, APHM | Marseille | France | |
| Hôpital CHU- Nantes | Nantes | France | |
| Diabetology department, Cochin Institute | Paris | France | |
| Diabetology departement, Lariboisière Hospital | Paris | France | |
| University Hospital Aachen | Aachen | Germany | |
| University Hospital Heidelberg | Heidelberg | Germany | |
| Amsterdam UMC | Amsterdam | Netherlands | |
| University Medical Center Groningen (UMCG), Cardiology/Cardio Research | Groningen | Netherlands | |
| Academisch ziekenhuis Maastricht, Cardiology | Maastricht | Netherlands | |
| UMC Utrecht, Cardiology (DHL) | Utrecht | Netherlands | |
| Hospital Vall Hebrón | Barcelona | Spain | |
| Institut D'Investigacions Biomedica August Pi I Sunyer (IDIBAPS) | Barcelona | Spain | |
| Hospital Gregorio Marañón | Madrid | Spain | |
| University of Dundee, Div of Molecular&Clinical Medicine | Dundee | United Kingdom |
More Institut National de la Santé Et de la Recherche Médicale, France trials in Spain
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04303364 on ClinicalTrials.gov ↗ ← All trials in Spain