CARdiomyopathy in Type 2 DIAbetes Mellitus

NCT04303364 | Active Not Recruiting DMC

• 1 other identifier: C19-10
• Study Type: observational
• Target: 1,256
• Locations: 5 countries
• Sites: 17

Brief 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.

Conditions

Cardiomyopathy, Diabetic

Keywords

Type2 Diabetes Mellitus; Heart Failure with preserved ejection fraction

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (3)

• Identify the best clinical, biological, imaging and multi-OMICs predictors belonging to each identified cluster

  4 years

• Assess prospective health outcomes (i.e. overall mortality, cardiovascular events and cardiac function) in the diabetic cardiomyopathy cluster identified

  5 years

• Explore the pathophysiological and potentially causal pathways characterizing diabetic cardiomyopathy

  5 years

Study Arms (6)

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• Patient covered by a health insurance
• Diabetes mellitus other than type 2 (type 1, LADA, MODY, NODAT, etc.)
• Suboptimal echocardiographic window

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (17)

Hopital Louis Pradel

Bron, 69677, France

Location

Cardiology Outpatient Department at Hôpital Henri Mondor.

Créteil, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, 38043, France

Location

department of diabetology and nutrition, APHM

Marseille, France

Location

Hôpital CHU- Nantes

Nantes, 44093, France

Location

Diabetology department, Cochin Institute

Paris, 75015, France

Location

Diabetology departement, Lariboisière Hospital

Paris, 75475, France

Location

University Hospital Aachen

Aachen, 52074, Germany

Location

University Hospital Heidelberg

Heidelberg, Germany

Location

Amsterdam UMC

Amsterdam, 1100 DD, Netherlands

Location

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

Groningen, Netherlands

Location

Academisch ziekenhuis Maastricht, Cardiology

Maastricht, Netherlands

Location

UMC Utrecht, Cardiology (DHL)

Utrecht, Netherlands

Location

Hospital Vall Hebrón

Barcelona, 08035, Spain

Location

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

Barcelona, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

University of Dundee, Div of Molecular&Clinical Medicine

Dundee, DD1 9SY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma EDTA, Serum, Paxgene RNA, Urine

MeSH Terms

Conditions

Diabetic Cardiomyopathies

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Geneviève DERUMEAUX, MD, PhD

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 11, 2020
• Study Start: October 2, 2020
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

NL (4); ES (3); GB (1); FR (7); DE (2)