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

NCT05830760 | Withdrawn

• 1 other identifier: 8774
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Valve Stenosis

Keywords

human heart; myocardium; aortic valve stenosis; heart failure; sodium glucose cotransporter 2

Outcome Measures

Primary Outcomes (2)

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

  Measure of SGLT2 expression level by RT-PCR and

  Day 0

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

  SGLT2 expression level by immunofluorescence labeling

  Day 0

Secondary Outcomes (7)

• Comparison of SGLT2 expression levels between heart failure and non-heart failure patients.

  Day 0

• Assess oxidative stress

  Day 0

• Evaluate the pro-inflammatory response by analysing the expression level of tissue activation molecules VCAM-1, ICAM-1, MCP-1

  Day 0

• Evaluate the pro-fibrotic response

  Day 0

• Evaluate the pro-senescent response

  Day 0

Study Arms (2)

patients with aortic valve stenosis with heart failure

EXPERIMENTAL

Biological: Myocardium biopsy

patients with aortic valve stenosis without heart failure

EXPERIMENTAL

Biological: Myocardium biopsy

Interventions

Myocardium biopsy BIOLOGICAL

The expression of SGLT2 on small myocardium specimens harvested during aortic valve replacement operation in patients with aortic stenosis

patients with aortic valve stenosis with heart failure; patients with aortic valve stenosis without heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Failure

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 26, 2023
• Study Start: June 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)