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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04303364
Other study ID # C19-10
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2, 2020
Est. completion date October 1, 2027

Study information

Verified date January 2024
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Geneviève DERUMEAUX, MD, PhD
Phone +33 (0)603613517
Email genevieve.derumeaux@inserm.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 1600
Est. completion date October 1, 2027
Est. primary completion date October 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 80 Years
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

Study Design


Locations

Country Name City State
France 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 departement, Lariboisière Hospital Paris
France Diabetology department, Cochin Institute Paris
Germany University Hospital Aachen Aachen
Germany University Hospital Heidelberg Heidelberg
Netherlands 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
Spain Hospital Vall Hebrón Barcelona
Spain Institut D'Investigacions Biomedica August Pi I Sunyer (IDIBAPS) Barcelona
Spain Hospital Gregorio Marañón Madrid
United Kingdom University of Dundee, Div of Molecular&Clinical Medicine Dundee

Sponsors (1)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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] 4 years
Secondary 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] 5 years
Secondary 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 5 years
See also
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