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Expression of Sodium-glucose Co-transporter 2 in Human Heart (SGLT2-MICRA)

U

University Hospital, Strasbourg, France

Status

Withdrawn

Conditions

Aortic Valve Stenosis

Treatments

Biological: Myocardium biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT05830760
8774 (Other Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

patients with aortic valve stenosis with heart failure
Experimental group
Treatment:
Biological: Myocardium biopsy
patients with aortic valve stenosis without heart failure
Experimental group
Treatment:
Biological: Myocardium biopsy

Trial contacts and locations

1

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Central trial contact

Jean Philippe MAZZUCOTELLI, Professor

Data sourced from clinicaltrials.gov

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