Understanding diabetic cardiomyopathy in patients with type 2 diabetes
CARdiomyopathy in Type 2 DIAbetes Mellitus
This study is trying to understand how diabetic cardiomyopathy affects people with type 2 diabetes differently than other heart problems to help improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Drugs / interventions | chemotherapy |
| Locations | 17 sites (Bron and 16 other locations) |
| Trial ID | NCT04303364 on ClinicalTrials.gov |
What this trial studies
The CARDIATEAM clinical study aims to explore the distinct characteristics of diabetic cardiomyopathy (DCM) compared to other types of cardiomyopathy. By utilizing unsupervised clustering techniques and deep phenotyping, the study will analyze a cohort of 1600 individuals, including both type 2 diabetes mellitus (T2DM) patients and non-diabetic individuals. The research will focus on a wide range of demographic, metabolic, and cardiac clinical data to clarify the progression of DCM towards heart failure with preserved ejection fraction (HFpEF). This comprehensive approach will help differentiate DCM from other heart failure forms through unbiased clustering analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40 to 80 years with type 2 diabetes or those without diabetes but meeting specific heart failure criteria.
Not a fit: Patients with significant heart failure symptoms or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of diabetic cardiomyopathy, potentially improving outcomes for patients with type 2 diabetes.
How similar studies have performed: Previous studies have explored aspects of diabetic cardiomyopathy, but the specific clustering approach used in this study is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bron and 16 other locations
- Hopital Louis Pradel — Bron, France (Recruiting)
- Cardiology Outpatient Department at Hôpital Henri Mondor. — Créteil, France (Recruiting)
- Centre Hospitalier Universitaire Grenoble Alpes — Grenoble, France (Recruiting)
- department of diabetology and nutrition, APHM — Marseille, France (Recruiting)
- Hôpital CHU- Nantes — Nantes, France (Recruiting)
- Diabetology department, Cochin Institute — Paris, France (Recruiting)
- Diabetology departement, Lariboisière Hospital — Paris, France (Recruiting)
- University Hospital Aachen — Aachen, Germany (Recruiting)
- University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- University Medical Center Groningen (UMCG), Cardiology/Cardio Research — Groningen, Netherlands (Recruiting)
- Academisch ziekenhuis Maastricht, Cardiology — Maastricht, Netherlands (Recruiting)
- UMC Utrecht, Cardiology (DHL) — Utrecht, Netherlands (Recruiting)
- Hospital Vall Hebrón — Barcelona, Spain (Recruiting)
- Institut D'Investigacions Biomedica August Pi I Sunyer (IDIBAPS) — Barcelona, Spain (Recruiting)
- Hospital Gregorio Marañón — Madrid, Spain (Recruiting)
- University of Dundee, Div of Molecular&Clinical Medicine — Dundee, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Geneviève DERUMEAUX, MD, PhD — Henri Mondor University Hospital
- Study coordinator: Geneviève DERUMEAUX, MD, PhD
- Email: genevieve.derumeaux@inserm.fr
- Phone: +33 (0)603613517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.