Using empagliflozin after aortic valve replacement
EMPagliflozin After Aortic Valve Replacement - the EMPAVR Study - a Randomized Clinical Trial
PHASE4 · Rigshospitalet, Denmark · NCT06171802
This study is testing if the medication empagliflozin can help people who have had aortic valve replacement surgery feel better and improve their heart function.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 205 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06171802 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled, double-blinded trial aimed at patients with aortic stenosis undergoing aortic valve replacement. Participants will be assigned to receive either empagliflozin or a placebo for six months following their surgery. The study will assess the effectiveness of empagliflozin in reducing left ventricular mass and improving symptoms through routine clinical check-ups and echocardiography. Blood samples and symptom scoring will also be part of the evaluation process.
Who should consider this trial
Good fit: Ideal candidates are patients with severe symptomatic aortic stenosis who are scheduled for surgical or transcatheter aortic valve replacement.
Not a fit: Patients with prior SGLT2i treatment, low ejection fraction, or significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients after aortic valve replacement.
How similar studies have performed: While the use of SGLT2 inhibitors in heart failure has shown promise, this specific application in post-aortic valve replacement is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Severe symptomatic aortic stenosis AND Surgical or transcatheter aortic valve replacement within 14 days Exclusion Criteria: * Prior treatment with a SGLT2i * Left ventricular ejection fraction \< 45% * Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min * Hypersensitivity to empagliflozin or placebo tablet * Type I Diabetes * Patients who do not understand Danish or English * Women who are pregnant or are nursing or plan to become pregnant during trial
Where this trial is running
Copenhagen
- University Hospital of Copenhagen, Rigshospitalet — Copenhagen, Denmark (RECRUITING)
Study contacts
- Principal investigator: Emil L. Fosbøl, MD, PhD — University Hospital of Copenhagen - Rigshospitalet
- Study coordinator: Louise M. Sørensen, MD
- Email: louise.marqvard.soerensen.02@regionh.dk
- Phone: 004535459520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Valve Stenosis, Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Aortic Valve, Sodium-Glucose Cotransporter-2 inhibitor, SGLT2i, Empagliflozin