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NCT05651919
PBMC as Biomarkers of Diabetic Cardiomyopathy
Conditions: Type 2 Diabetes, Metabolic Syndrome, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Sex: All
Ages: 40 Years – 80 Years
Enrollment: 60
Sponsor: Hospices Civils de Lyon
Location: France
Summary
Type 2 diabetes (T2D), especially when associated with metabolic syndrome (MS) is at high risk to develop heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF), and the specific impact of T2D+MS in cardiac function impairment is usually known as "diabetic cardiomyopathy" (DC).
Cardiac remodelling (ie hypertrophy) and subtle myocardial dysfunction are highly prevalent in T2D+MS but not specific enough to predict further HFpEF or HFmrEF.
Also, current biomarkers can identify but do not predict HFpEF or HFmrEF in T2D patients; Furthermore, specific biomarkers are needed.
Peripheral blood mononuclear cells (PBMC) obtained from a peripheral blood sample can provide insights from calcic and inflammatory pathways, and may identify more specific molecular signatures shared between T2D+MS and HFpEF.
Eligibility Criteria
Inclusion Criteria:Inclusion criteria common to the 4 groups:Patient coming for a scheduled cardiology or endocrinology visit as part of their follow-upPatient coming on an empty stomach for the blood testMale or female aged between 40 and 80 inclusivePatient without systemic disease and/or without anti-inflammatory treatmentPatient not objecting to this researchPatient accepting the conservation of biological samples and the performance of genetic analyzesGroup 1: No-T2D +MS / No-HF (control group)Patient without T2D or MS and without heart failure coming to a consultation or day hospital for another reason (e.g.
screening for atypical symptom, etc.)Group 2: No-T2D +MS / HFpEF or HFmrEFPatient without T2D or MSHFpEF or HFmrEF. diagnosedGroup 3: T2D+MS / no-HFPatient diagnosed with T2D+MSGroup 4: T2D +MS / HFpEF or HFmrEFPatient diagnosed with T2D and MSHFpEF or HFmrEF. diagnosedExclusion Criteria:Non-inclusion criteria common to the 4 groups:History (ATCD) of cardiovascular disease (valvular (more than moderate valve disease), radiation, post-cardiotoxic chemotherapy, amyloidosis, etc.) other than HFpEF or HFmrEFAtrial fibrillation or permanent flutterSystemic disease and/or anti-inflammatory treatmentATCD of known coronary artery diseaseUnbalanced hypertension (>160/100 mmHg)Pregnant and lactating women on questioningPersons deprived of their liberty by a judicial or administrative decisionPersons subject to psychiatric carePatients subject to a legal protection measure (guardianship, curators)Subject participating in another interventional research including a period of exclusion still in progress.Group 1: No-T2D +MS / No-HF (control group)Presence of diabetes (whatever the type) and MSPresence of heart failure or other known heart diseaseGroup 2: No-T2D +MS / HFpEF or HFmrEFPresence of diabetes (whatever the type) and MSNo Heart failureLeft Ventricular Ejection Fraction (LVEF) on ultrasound ≤ 40%Group 3: T2D+MS / no-HFWithout diabetes or other type of diabetes than T2DPresence of Heart failure or other known coronary artery diseaseGroup 4: T2D +MS / HFpEF or HFmrEFAbsence of diabetes or presence of another type of diabetes than T2DAbsence of Heart failureLVEF on ultrasound ≤ 40%
Source: ClinicalTrials.gov (NCT05651919). StuddyBuddy aggregates publicly available trial information.