Using blood samples to identify heart failure risks in diabetes patients
Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy
This study is trying to see if blood tests can help find out which people with type 2 diabetes are at risk for heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 175 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bron) |
| Trial ID | NCT05651919 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between type 2 diabetes, metabolic syndrome, and heart failure by analyzing peripheral blood mononuclear cells (PBMC) as potential biomarkers. It focuses on patients with varying conditions, including those with and without heart failure, to identify specific molecular signatures that could predict heart failure risk. Participants will undergo blood tests and complete questionnaires regarding their quality of life and dietary habits. The study seeks to enhance understanding of diabetic cardiomyopathy and improve predictive capabilities for heart failure in diabetic patients.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40 to 80 with type 2 diabetes and/or metabolic syndrome, as well as those without these conditions but with heart failure.
Not a fit: Patients with systemic diseases or those undergoing anti-inflammatory treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of heart failure in patients with type 2 diabetes and metabolic syndrome.
How similar studies have performed: While the approach of using PBMC as biomarkers is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion criteria common to the 4 groups: * Patient attending a scheduled cardiology or endocrinology follow-up visit * Patient fasting for blood sampling * Male or female aged 40 to 85 years inclusive * Patient not opposing participation in this research * Patient agreeing to the storage of biological samples and to genetic analyses Group 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 HFmrEF * Patient without T2D or MS * HFpEF or HFmrEF. diagnosed Group 3: T2D+MS / no-HF * Patient diagnosed with T2D+MS * \- Absence of HF Group 4: T2D +MS / HFpEF or HFmrEF * Patient diagnosed with T2D and MS * HFpEF or HFmrEF. diagnosed Exclusion Criteria: Non-inclusion criteria common to the 4 groups: * History of cardiovascular disease (valvular disease \[greater than moderate severity\], radiation-induced, post-cardiotoxic chemotherapy, amyloidosis, etc.) other than HFpEF or HFmrEF * Acute or ongoing systemic inflammatory or infectious disease * History of known coronary artery disease * Uncontrolled hypertension (\>160/100 mmHg) * Pregnant or breastfeeding women (based on interview) * Persons deprived of liberty by judicial or administrative decision * Persons undergoing psychiatric care * Patient under legal protection (guardianship or curatorship) * Subject participating in another interventional study with an ongoing exclusion period * Chronic kidney disease (eGFR \<30 mL/min/1.73 m²) Group 1: No-T2D +MS / No-HF (control group) * Presence of diabetes (whatever the type) and MS * Presence of heart failure or other known heart disease Group 2: No-T2D +MS / HFpEF or HFmrEF * Presence of diabetes (whatever the type) and MS * Left Ventricular Ejection Fraction (LVEF) on ultrasound ≤ 40% Group 3: T2D+MS / no-HF * Without diabetes or other type of diabetes than T2D * Presence of Heart failure (all types) Group 4: T2D +MS / HFpEF or HFmrEF * Absence of diabetes or presence of another type of diabetes than T2D * LVEF on ultrasound ≤ 40%
Where this trial is running
Bron
- Hopital Louis Pradel — Bron, France (Recruiting)
Study contacts
- Study coordinator: Hélène THIBAULT, PU,PH
- Email: Helene.thibault@chu-lyon.fr
- Phone: 0427856691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.