Heart valve trouble? a diabetes drug may shield the heart muscle — trial puts it to the test
NCT ID NCT06469645
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial tests whether empagliflozin, a drug already used for diabetes and heart failure, can prevent the heart muscle from thickening or developing fibrosis in people with moderate aortic stenosis. Participants will receive either empagliflozin or standard care for six months, with heart changes tracked by MRI and echocardiography. The goal is to see if this medication can ease the extra strain on the heart caused by a narrowed aortic valve.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- empagliflozin 10 mg once daily
- What this could lead to
- If it works, this could point toward a medication that slows or prevents heart muscle thickening and fibrosis in aortic stenosis, potentially reducing the need for surgery.
- What could go wrong
- This is a mid-stage trial with 104 participants, so results may not apply broadly. SGLT2 inhibitors can cause side effects like dehydration, urinary infections, or rare cases of diabetic ketoacidosis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
104 people
The number who actually took part.
- Started
-
May 2024
- Finished
-
Jul 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Moderate aortic stenosis (aortic valve peak velocity ≥ 3m/s or mean gradient 20-40mmHg, or Aortic valve area 1.0-1.5cm2) 2. Age over 18 years Exclusion Criteria: 1. 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. 2. Previous valve replacement 3. Severe hypertension (systolic \>180mmHg or diastolic \>100mmHg) 4. Acute pulmonary oedema or cardiogenic shock 5. Coexisting other valvular lesion of more than moderate severit. 6. Coexisting hypertrophic cardiomyopathy or amyloidosis with cardiac involvement 7. Any contraindications to MRI scanning including eGFR \<30ml/min/1.73m2 8. Pregnancy or breast-feeding 9. Concomitant SGLT2 inhibitor therapy 10. Inability to receive SGLT2 inhibitor therapy 11. History of diabetes type 1 or 2 12. Severe peripheral vascular disease or non-healed leg ulcers 13. Severe liver disease 14. Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
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