A Phase 2/3 interventional study of Empagliflozin 10 MG in Moderate Aortic Valve Stenosis, sponsored by University of East Anglia. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by University of East Anglia · Phase 2/3, Interventional, and Prevention
Background:
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.
Background:
Aortic stenosis represents one of the commonest valvular heart diseases in the Western World. Studies have shown that as the valvular narrowing progresses, pathological left ventricular (LV) hypertrophy and fibrosis develop. This maladaptive left ventricular remodelling is associated with adverse events and worse long-term prognosis. Currently, there is no available medication to slow down or prevent these pathological processes occurring in aortic stenosis. Evidence from recent large randomised controlled trials have demonstrated that SGLT2 inhibitors have a significant positive impact on quality of life and cardiovascular outcomes of patients with heart failure. This is a result of complex mechanisms such as attenuation of cardiac myofibroblast activity and collagen remodelling. These could be proved to be very beneficial for patients with aortic stenosis since the left ventricular pathological changes occurring in aortic stenosis share similar pathways and mechanisms with heart failure.
Study aims and objectives:
The aims of this study are to assess if:
Methods:
Given that the use of SGLT2 inhibitors in aortic stenosis has not been investigated before, we aim to investigate the hypotheses with an early stage randomised controlled trial. For this, patients with moderate aortic stenosis identified in the outpatient cardiology clinic will be invited to participate. Management of moderate aortic stenosis is conservative with a 'watchful waiting' approach. The participants will be randomised either to usual conservative management or to the intervention group (use of SGLT2 inhibitor on top of regular medications). They will be assessed at baseline and at 6-months following initiation of the medication. Both appointments will include evaluation of symptoms (with the use of validated questionnaire) and functional capacity (cardiopulmonary exercise test), electrocardiogram and blood tests. An echocardiogram, a scan performed routinely on a yearly basis for all patients with moderate aortic stenosis, will also be performed at baseline and at completion of the 6 months' follow-up period to evaluate for myocardial hypertrophy and remodelling. Additionally, a cardiopulmonary exercise test and a cardiac magnetic resonance scan will be performed in these two timepoints to assess for myocardial remodelling and fibrosis.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's enrollment of 104 is below the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →University of East Anglia is the lead sponsor of 79 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomised in this group will be taking the SLGT2 inhibitor (empagliflozin) on top of their regular medications for 6 months.
Drug: Empagliflozin 10 MG
Patients randomised in this group will continue to have their guideline directed conservative management with no changes in their regular medications.
Participants allocated in the Intervention Group will be taking empagliflozin 10mg once a day on top of their regular medications.
Change in indexed extracellular volume (iECV)
The indexed extracellular volume (iECV) (expressed in ml/m2) will be assessed from the Cardiac Magnetic Resonance Scan at baseline and at 6 months follow-up
Time frame: 6 months
Change in left ventricular ejection fraction
Left ventricular ejection fraction (expressed in percentage, %) will be assessed from the Cardiac Magnetic Resonance Scan at baseline and at 6 months follow-up
Time frame: 6 months
Change in left ventricular diastolic function as assessed by the E/A ratio
Diastolic function will be assessed from the echocardiographic assessment at baseline and at 6 months follow-up
Time frame: 6 months
Change in indexed left ventricular mass
Change in indexed left ventricular mass (expressed in g/m2) will be assessed from the Cardiac Magnetic Resonance Scan at baseline and at 6 months follow-up
Time frame: 6 months
Change in percentage of myocardial uptake of late gadolinium enahncement (LGE)
The late gadolinium enhancement will be assessed visually and quantitatively (% of left ventricular mass) from the Cardiac Magnetic Resonance Scan at baseline and at 6 months follow-up
Time frame: 6 months
Change in cardiac markers (N-terminal pro b-type natriuretic peptide and high sensitivity troponin)
Participants will have their cardiac markers (N-terminal pro b-type natriuretic peptide and high sensitivity troponin) tested at baseline and at the 6-month follow-up visit.
Time frame: 6 months
Change in peak oxygen consumption (VO2) as assessed by Cardio-Pulmonary Exercise Test
Participants will undergo a Cardio-pulmonary Exercise Test at baseline and at 6-months follow-up. The peak oxygen consumption will be assessed and changes will be recorded.
Time frame: 6 months
Change in Quality of Life (QoL) as assessed with the Kansas City Cardiomyopathy Questionnaire
Participants will complete the Kansas City Cardiomyopathy Questionnaire at the baseline visit and at the 6-month follow up visit. The score of the Questionnaire scales from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2024 to primary completion in Jul 2026, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
Studies of the drug tested here: Empagliflozin
University of East Anglia