CClinicalTrials.gg
WithdrawnNCT05830760SGLT2-MICRAUpdated Dec 23, 2025

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

An interventional study of Myocardium biopsy in Aortic Valve Stenosis, sponsored by University Hospital, Strasbourg, France. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Basic science

Why this study was withdrawn
authorization obsolete
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aortic Valve Stenosis

Keywords

  • human heart
  • myocardium
  • aortic valve stenosis
  • heart failure
  • sodium glucose cotransporter 2
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 282 are open to participants now.

Browse Aortic Valve Stenosis studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 968 studies on the registry; 344 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    patients with aortic valve stenosis with heart failure

    Biological: Myocardium biopsy

  • Experimental
    patients with aortic valve stenosis without heart failure

    Biological: Myocardium biopsy

Interventions

  • BiologicalMyocardium biopsy

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 0

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

    SGLT2 expression level by immunofluorescence labeling

    Time frame: Day 0

Secondary outcomes

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

    SGLT2 expression levels between the 2 groups of patients

    Time frame: Day 0

  2. Assess oxidative stress

    Pro-oxidant response (fluorescence level of the redox-sensitive fluorescent probe DHE)

    Time frame: Day 0

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

    Pro-inflammatory response: (VCAM-1, ICAM-1, MCP-1). Expression level of tissue activation molecules VCAM-1, ICAM-1, MCP-1 by RT-PCR, Western blot analysis and immunofluorescence labeling

    Time frame: Day 0

  4. Evaluate the pro-fibrotic response

    Pro-fibrotic response: TGF beta, Ang II, AT1R, ACE, collagen; MMP-2, MMP-9. Expression level of molecules involved in tissue remodeling TGF beta, Ang II, AT1R, ACE, collagen, MMP-2, MMP-9 by RT-PCR, Western blot analysis and immunofluorescence labeling

    Time frame: Day 0

  5. Evaluate the pro-senescent response

    Pro-senescent response: SA-beta-galactosidase activity, p53, p21, P16. Determination of senescence-associated beta-galactosidase activity on cardiac muscle cryosections, and expression level of senescence mediators p53, p21, p16 by RT-PCR, Western blot analysis and immunofluorescence labeling

    Time frame: Day 0

  6. Evaluate the pro-thrombotic response

    Pro-thrombotic response: tissue factor. Expression level of coagulation cascade activator, tissue factor by RT-PCR, Western blot analysis and immunofluorescence labeling

    Time frame: Day 0

  7. Evaluate endothelial dysfunction

    Endothelial response: eNOS, NO, nitrotyrosine. Expression level of eNOS and nitrotyrosine by RT-PCR, Western blot analysis and immunofluorescence labeling and NO formation using the NO-sensitive fluorescent probe, DAF-FM on heart muscle cryosections

    Time frame: Day 0

07

Study locations

1 site
  • Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67098, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05830760
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Apr 26, 2023
Start date
Jun 2023 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Dec 23, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion