Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype (NCT05181631) | Clinical Trial Compass
UnknownNot Applicable
Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype
1,500 participantsStarted 2022-01-15
Plain-language summary
"Little is known about the prevalence, determinants and phenotypes of the cardiomyopathy associated with diabetes and/or metabolic syndrome. The emergence of new therapies (SGLT2 inhibitors) that may mitigate and even prevent the onset of heart failure offers new opportunities.The objective of this protocol is to evaluate the prevalence and phenotypes of cardiomyopathy confirmed by echography in people at high metabolic risk defined as living with diabetes or obesity."
Who can participate
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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:
* Adults (18 years-old or more)
* At high metabolic risk: diabetes of any type and/or obesity (body mass index ≥ 30 kg/m²)
* Admission in the departement of Diabetology-Obesity-Nutrition, Avicenne Hospital, Bobigny, France
* Patient informed and having signed consent
* Patient affiliated to a social security scheme or entitled
Exclusion Criteria:
* Any know cardiac disease: coronary artery disease, heart failure, cardiomyopathy, pulmonary embolism \< 6 months, pulmonary hypertension, rhythm disorders \< 6 months
* Blood pressure \> 180/110 mmHg
* Severe renal failure as defined by estimated glomerular filtration rate \< 30 ml/min
* Age ≥ 80 years
* Previous inclusion in the study
* Patient under guardianship curatorship
* Patient on AME (aide médicale d'état)
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.