WithdrawnNot Applicable

Expression of Sodium-glucose Co-transporter 2 in Human Heart

Stopped: authorization obsolete

France0Started 2023-06

Plain-language summary

The aim of the study is to evaluate the expression of Sodium Glucose Co-transporter 2 (SGLT2) in myocardium from patients with aortic stenosis. 2 groups of patients will be defined: Group A with diastolic heart failure and Group B without heart failure. The expression of SGLT2 will be measured on small myocardium specimens harvested during aortic valve replacement operation. This study should allow us to better understand the effect of glifozines in human heart failure.

Who can participate

Age range

18 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: * adults over 18 years-old * Patient with surgical aortic valve stenosis, with or without heart failure, in two equal-sized groups (40 subjects in each group) * Subjects affiliated with a social security health insurance plan * Subject able to understand the objectives and risks of the research and to give dated and signed informed consent Exclusion Criteria: * Infective endocarditis in aortic stenosis * Severe coronary pathology associated with aortic stenosis * Impossible to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...) * Subject under legal protection * Subject under guardianship or curatorship * Pregnancy and/or breastfeeding

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

To study the expression levels of SGLT2 in the myocardium of patients with surgical aortic stenosis

Timeframe: Day 0

To study the SGLT2 tissue localization in the myocardium of patients with surgical aortic stenosis

Timeframe: Day 0

Trial details

NCT IDNCT05830760

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10

View on ClinicalTrials.gov More Aortic Valve Stenosis trials