The Role of SGLT2i in Management of Moderate AS
Key facts
- Who runs it
- University of East Anglia
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2/3
- People taking part
- 104 people enrolled
- Started
- 30 May 2024
- Ended
- 24 Jul 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Empagliflozin 10 MG
- Record updated
- 28 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Moderate aortic stenosis (aortic valve peak velocity ≥ 3m/s or mean gradient 20-40mmHg, or Aortic valve area 1.0-1.5cm2)
- Age over 18 years
Who cannot take part
- Previous valve replacement
- Concomitant SGLT2 inhibitor therapy
- Inability to receive SGLT2 inhibitor therapy
- Severe aortic stenosis (aortic valve peak velocity ≥ 4m/s or mean > 40mmHg or Aortic valve area < 1.0cm2) or planned cardiac surgery or likely need for surgery within 6 months
- Severe hypertension (systolic >180mmHg or diastolic >100mmHg)
- Coexisting hypertrophic cardiomyopathy or amyloidosis with cardiac involvement
- History of diabetes type 1 or 2
- Severe peripheral vascular disease or non-healed leg ulcers
- Severe liver disease
- Any contraindications to MRI scanning including eGFR <30ml/min/1.73m2
- Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
- Acute pulmonary oedema or cardiogenic shock
- Coexisting other valvular lesion of more than moderate severit
- Pregnancy or breast-feeding
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Background:
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The aortic valve is like a door in the heart that lets blood flow out to the body. Over time, this valve can get worn out and become too narrow, leading to a condition called aortic stenosis. When this happens, the heart has to work extra hard to push blood through the narrow valve to supply the body with what it needs. This extra effort can cause the heart muscle to become abnormally thick or to have fibrosis. For people with aortic stenosis, this can lead to more problems like feeling out of breath, chest pain, and even needing to go to the hospital. It also increases the risk of dying from heart issues. There is a type of medication called Sodium Glucose Cotransporter 2 (SGLT2) inhibitors, which has been studied in people with weak heart muscle. These medicines were found to help the heart work better and improve the pumping of blood around the body. This can be promising for patients with aortic stenosis because it might make the heart muscle stronger and protect it from damage.
Aim of research study:
The aim of this study is to investigate whether the use of the drug empagliflozin, an SGLT2 inhibitor, prevents the formation of fibrosis or the abnormal thickening of the heart muscle in patients with aortic stenosis. Using advanced imaging techniques (such as echocardiography and cardiovascular magnetic resonance), we intend to study their effect on the heart muscle of patients with aortic stenosis.
Study design:
Patients with moderate aortic stenosis will be invited for participation. Eligible consenting patients will have a baseline assessment with cardiac MRI scan, echocardiography, cardiopulmonary exercise test and validated quality of life questionnaires. They will then be randomised to receive either the SGLT2i for 6 months, or standard of care. All patients will undergo the same tests at 6 months. This way, we aim to investigate the potential changes in the heart muscle and whether the SGLT2 inhibitor prevents fibrosis or hypertrophy.
The 2 groups in the trial
- Intervention GroupTreatment being tested
Patients randomised in this group will be taking the SLGT2 inhibitor (empagliflozin) on top of their regular medications for 6 months.
Treatment: Empagliflozin 10 MG
- Control GroupNo study treatment, for comparison
Patients randomised in this group will continue to have their guideline directed conservative management with no changes in their regular medications.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Role of Sodium Glucose Cotransporter 2 Inhibitors in the Management of Patients With Aortic Stenosis
- Record updated
- 28 July 2026