Aortic Valve StenosisSGLT2-MICRANCT05830760
Expression of Sodium-glucose Co-transporter 2 in Human Heart
A study testing Myocardium biopsy in people with Aortic Valve Stenosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Myocardium biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Expression of Sodium Glucose Co-transporter2 in Myocardium From Patients With Aortic Valve Stenosis and With/Without Diastolic Heart Failure
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
- Being tested
- Myocardium biopsy
- Keywords
- human heart, myocardium, aortic valve stenosis, heart failure, sodium glucose cotransporter 2
- Medical subject headings
- Aortic Valve Stenosis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardium biopsyBiological
The expression of SGLT2 on small myocardium specimens harvested during aortic valve replacement operation in patients with aortic stenosis
| Study group | Role | What they receive |
|---|---|---|
| patients with aortic valve stenosis with heart failure | Experimental | Not described Receives: Biological: Myocardium biopsy |
| patients with aortic valve stenosis without heart failure | Experimental | Not described Receives: Biological: Myocardium biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
To study the SGLT2 tissue localization in the myocardium of patients with surgical aortic stenosis
SGLT2 expression level by immunofluorescence labeling
Measured: Day 0
Secondary outcomes (7)
Comparison of SGLT2 expression levels between heart failure and non-heart failure patients.
SGLT2 expression levels between the 2 groups of patients
Measured: Day 0
Assess oxidative stress
Pro-oxidant response (fluorescence level of the redox-sensitive fluorescent probe DHE)
Measured: Day 0
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
Measured: Day 0
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
Measured: Day 0
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
Measured: Day 0
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
Measured: Day 0
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study startJun 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: authorization obsolete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830760
- Sponsor's protocol ID
- 8774
- Acronym
- SGLT2-MICRA
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Sodium Glucose Co-transporter2 in Myocardium From Patients With Aortic Valve Stenosis and With/Without Diastolic Heart Failure
- ClinicalTrials.gov ID
- NCT05830760
- Acronym / sponsor ID
- SGLT2-MICRA / 8774
- Conditions
- Aortic Valve Stenosis
- Keywords
- human heart, myocardium, aortic valve stenosis, heart failure, sodium glucose cotransporter 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: authorization obsolete
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with aortic valve stenosis with heart failure | Experimental | Biological: Myocardium biopsy |
| patients with aortic valve stenosis without heart failure | Experimental | Biological: Myocardium biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myocardium biopsyThe expression of SGLT2 on small myocardium specimens harvested during aortic valve replacement operation in patients with aortic stenosis | Biological | patients with aortic valve stenosis with heart failure, patients with aortic valve stenosis without heart failure |
Primary outcome
To study the expression levels of SGLT2 in the myocardium of patients with surgical aortic stenosis
Time frame: Day 0
Measure of SGLT2 expression level by RT-PCR and
To study the SGLT2 tissue localization in the myocardium of patients with surgical aortic stenosis
Time frame: Day 0
SGLT2 expression level by immunofluorescence labeling
7 secondary outcomes
Comparison of SGLT2 expression levels between heart failure and non-heart failure patients.
Time frame: Day 0
Assess oxidative stress
Time frame: Day 0
Evaluate the pro-inflammatory response by analysing the expression level of tissue activation molecules VCAM-1, ICAM-1, MCP-1
Time frame: Day 0
Evaluate the pro-fibrotic response
Time frame: Day 0
Evaluate the pro-senescent response
Time frame: Day 0
Evaluate the pro-thrombotic response
Time frame: Day 0
Evaluate endothelial dysfunction
Time frame: Day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myocardium biopsy in people with Aortic Valve Stenosis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the expression levels of SGLT2 in the myocardium of patients with surgical aortic stenosis (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.