PBMC as Biomarkers of Diabetic Cardiomyopathy (NCT05651919) | Clinical Trial Compass
RecruitingNot Applicable
PBMC as Biomarkers of Diabetic Cardiomyopathy
France175 participantsStarted 2023-05-23
Plain-language 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.
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of Initial level of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF
Timeframe: Day of blood sample (inclusion visit)
2
Comparison of amplitude of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF
Timeframe: Day of blood sample (inclusion visit)
3
Comparison of area under curve of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF
Timeframe: Day of blood sample (inclusion visit)
4
Comparison of slope of the response to pharmacological stimulation of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF
Timeframe: Day of blood sample (inclusion visit)
5
Comparison of the inflammatory profile of PBMC from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF