CARdiomyopathy in Type 2 DIAbetes Mellitus

Status: Recruiting
Location: See all (17) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
Hopital Louis Pradel
RECRUITING
Bron
Cardiology Outpatient Department at Hôpital Henri Mondor.
RECRUITING
Créteil
Centre Hospitalier Universitaire Grenoble Alpes
RECRUITING
Grenoble
department of diabetology and nutrition, APHM
RECRUITING
Marseille
Hôpital CHU- Nantes
RECRUITING
Nantes
Diabetology departement, Lariboisière Hospital
RECRUITING
Paris
Diabetology department, Cochin Institute
RECRUITING
Paris
Germany
University Hospital Aachen
RECRUITING
Aachen
University Hospital Heidelberg
RECRUITING
Heidelberg
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
University Medical Center Groningen (UMCG), Cardiology/Cardio Research
RECRUITING
Groningen
Academisch ziekenhuis Maastricht, Cardiology
RECRUITING
Maastricht
UMC Utrecht, Cardiology (DHL)
RECRUITING
Utrecht
Spain
Hospital Vall Hebrón
RECRUITING
Barcelona
Institut D'Investigacions Biomedica August Pi I Sunyer (IDIBAPS)
RECRUITING
Barcelona
Hospital Gregorio Marañón
RECRUITING
Madrid
United Kingdom
University of Dundee, Div of Molecular&Clinical Medicine
RECRUITING
Dundee
Contact Information
Primary
Geneviève DERUMEAUX, MD, PhD
genevieve.derumeaux@inserm.fr
+33 (0)603613517
Backup
Anne PIZARD, PhD
anne.pizard@inserm.fr
+33(0)627658563
Time Frame
Start Date: 2020-10-02
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 1600
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Institut National de la Santé Et de la Recherche Médicale, France
Collaborators: Consorcio Centro de Investigación Biomédica en Red (CIBER)

This content was sourced from clinicaltrials.gov