Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1600 participants
OBSERVATIONAL
2020-10-02
2028-04-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects without T2DM and without HF
No interventions assigned to this group
Patients without T2DM and with HFpEF
No interventions assigned to this group
Patients with T2DM and without HFpEF
No interventions assigned to this group
Patients with T2DM and HFpEF
No interventions assigned to this group
Patients without T2DM and with hypertrophic cardiomyopathy
No interventions assigned to this group
Patients with T2DM and with hypertrophic cardiomyopathy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
Yes
Sponsors
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Consorcio Centro de Investigación Biomédica en Red (CIBER)
OTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Geneviève DERUMEAUX, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Henri Mondor University Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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C19-10
Identifier Type: -
Identifier Source: org_study_id
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