Using blood samples to identify heart failure risks in diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hopital Louis Pradel
  Bron, France Recruiting

Study contacts

• Study coordinator: Hélène THIBAULT, PU,PH
• Email: Helene.thibault@chu-lyon.fr
• Phone: 0427856691

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.