Phase
Condition
Diabetes Mellitus, Type 2
Diabetes And Hypertension
Circulation Disorders
Treatment
N/AClinical Study ID
Ages 40-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
Study Description
Connect with a study center
Hopital Louis Pradel
Bron, 69677
FranceActive - Recruiting
Cardiology Outpatient Department at Hôpital Henri Mondor.
Créteil,
FranceActive - Recruiting
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38043
FranceActive - Recruiting
Hopital Louis Pradel
Lyon,
FranceSite Not Available
department of diabetology and nutrition, APHM
Marseille,
FranceActive - Recruiting
Hôpital CHU- Nantes
Nantes, 44093
FranceActive - Recruiting
Diabetology departement, Lariboisière Hospital
Paris, 75475
FranceActive - Recruiting
Diabetology department, Cochin Institute
Paris, 75015
FranceActive - Recruiting
University Hospital Aachen
Aachen, 52074
GermanyActive - Recruiting
University Hospital Heidelberg
Heidelberg,
GermanyActive - Recruiting
Amsterdam UMC
Amsterdam, 1100 DD
NetherlandsActive - Recruiting
Amsterdam UMC, location VUmc
Amsterdam,
NetherlandsSite Not Available
University Medical Center Groningen (UMCG), Cardiology/Cardio Research
Groningen,
NetherlandsActive - Recruiting
Academisch ziekenhuis Maastricht, Cardiology
Maastricht,
NetherlandsActive - Recruiting
UMC Utrecht, Cardiology (DHL)
Utrecht,
NetherlandsActive - Recruiting
Hospital Vall Hebrón
Barcelona, 08035
SpainActive - Recruiting
Institut D'Investigacions Biomedica August Pi I Sunyer (IDIBAPS)
Barcelona,
SpainActive - Recruiting
Hospital Gregorio Marañón
Madrid, 28007
SpainActive - Recruiting
University of Dundee, Div of Molecular&Clinical Medicine
Dundee, DD1 9SY
United KingdomActive - Recruiting
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