Aortic Valve StenosisPhase 4EMPAVRNCT06171802
EMPagliflozin After Aortic Valve Replacement
A Phase 4 study testing Empagliflozin in people with Aortic Valve Stenosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study is a randomized, placebo-controlled, and double-blinded trial in patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR). After AVR, patients will be randomized 1:1 to empagliflozin (SGLT2i) or placebo to investigate whether empagliflozin is superior to placebo in reducing left… 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?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Feb 2024to 18 May 2026
- Phase
- Phase 4
- 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
- Severe symptomatic aortic stenosis AND Surgical or transcatheter aortic valve replacement within 14 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, 2100
About this study
Official title: EMPagliflozin After Aortic Valve Replacement - The EMPAVR Study - A Randomized Clinical Trial
The study is a randomized, placebo-controlled, and double-blinded trial in patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR). After AVR, patients will be randomized 1:1 to empagliflozin (SGLT2i) or placebo to investigate whether empagliflozin is superior to placebo in reducing left ventricular mass and improve symptoms to 6 months.
Read the detailed description
In this randomized, placebo-controlled, and double-blinded trial we investigate whether empagliflozin (SGLT2i) is superior to placebo in reducing left ventricular mass and improve symptoms.
All patients with AS who are referred to Rigshospitalet for AVR (both surgical and transcatheter approaches) will be screened for in- and exclusion criteria in the medical record based on the Danish Health Act §46 by the PI, co-PI, or a delegated study nurse. If the patient fulfills the inclusion criteria and none of the exclusions criteria, the patient is invited to participate in the study.
Included patients will be randomized 1:1 in blocks of 2, 4, and 6 patients to either Empagliflozin 10 mg daily or placebo. Point of randomization will be in the hospital when the patients has undergone AVR.
The total treatment period is 6 months with either 10 mg Empagliflozin or placebo. The trial participants will receive conventional treatment, which will be carried out irrespective of the inclusion in the trial in accordance with national guidelines. Routine clinical check-ups irrespective of the trial setup will be performed at 3 months after discharge, and study-outcomes will be assessed at discharge, 3 months, and 6 months (eg. echocardiography). Blood samples (including N-Terminal-proBNP, renal function and electrolytes, hemoglobin and HbA1c) will be part of such routine visits as well as a standardized symptom-scoring tool (KCCQ and NYHA classification). Compliance will be evaluated at 1-, 3- and 6-months. The assessment for 1-month will be per telephone and the assessment at 3- and 6-months will be at the routine clinical check-ups in the outpatient clinic.
The CT scan performed in the planning of the procedure will be used for the baseline assessment (before AVR). An identical exam (CT scan) will be performed at 6 months to assess change in LV mass.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Empagliflozin, Placebo
- Keywords
- Aortic Valve Stenosis, Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Aortic Valve, Sodium-Glucose Cotransporter-2 inhibitor, SGLT2i, Empagliflozin
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
10 mg empagliflozin daily for six months
PlaceboDrug
Placebo capsule once daily for six months
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Active comparator | Empagliflozin 1 capsule of 10 mg, once daily for six months. Receives: Drug: Empagliflozin |
| Placebo | Placebo comparator | 1 capsule of placebo, once daily for six months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass indexed to body surface area
Change in left ventricular mass indexed to body surface area (measured by CT) from pre-Aortic Valve Replacement to 6-months post-Aortic Valve Replacement
Measured: 6 months from discharge post-Aortic Valve Replacement
Secondary outcomes (10)
LVESVi
Left ventricular end-systolic volume indexed to body surface (LVESVi) (measured by CT)
Measured: 6-months from discharge post-aortic valve replacement
LV GLS (echo)
Left ventricular global longitudinal strain (LV GLS) (measured by echocardiography)
Measured: 3- and 6-months from discharge
N-terminal pro B-type natriuretic peptide (NT-proBNP) change
NT-proBNP change from baseline to 6 months
Measured: 3- and 6-months from discharge
Death and readmission for any non-planned cause
A composite outcome of death and readmission for any non-planned cause
Measured: 6 months from discharge date (after aortic valve replacement)
Death
Death during follow-up, from discharge to 6-months after discharge
Measured: 6 months from discharge date (after aortic valve replacement)
Readmission for any cause
Readmission for any cause to any hospital after discharge
Measured: 6 months from discharge date (after aortic valve replacement)
Admission for heart failure
Admission for heart failure to any hospital
Measured: 6 months from discharge date (after aortic valve replacement)
Kansas City Cardiomyopathy Questionaire (KCCQ)
Change in symptom score (KCCQ) at 6-months. KCCQ scores are scaled from 0 to 100, where scores represent health status as follows: 0-24: very poor to poor; 25-49: poor to fair; 50-74: fair to good; and 75-100: good to excellent.
In this study a change of 5 points is considered a meaningful change.
Measured: 6 months from discharge date (after aortic valve replacement)
Quality of Life (QoL) - The Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Quality of life assessment at baseline and 6 months after discharge post-AVR using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
MLHFQ consist of 21 questions. The response format ranges from 0 (none or not applicable), to 1 (very little) to 5 (very much). The sum of responses ranges from 0 to 105. The score increases with adverse impact of the disease on the respondent's life.
Measured: 6 months from discharge date (after aortic valve replacement)
New York Heart Association (NYHA) Functional Classification
Change in symptom score at 6 months (NYHA classification).
The NYHA classification places patients in one of four categories based on limitations of physical activity. Class I: No limitation of physical activity; Class II: Slight limitation of physical activity; Class III: Marked limitation of physical activity; Class IV: Symptoms of heart failure at rest.
Measured: 3- and 6-months from discharge date (after aortic valve replacement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start14 Feb 2024
- Primary completion8 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emil Loldrup Fosbol, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Emil L. Fosbøl, MD, PhD, Principal investigator, University Hospital of Copenhagen - Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171802
- Sponsor's protocol ID
- 2023-504731-40-01
- Other IDs
- 2023
- Acronym
- EMPAVR
- Status last verified
- May 2026
- First submitted
- 23 Nov 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sorensen LM, Reinert MS, Raja AA, de Backer O, Bieliauskas G, Schou M, Jensen J, Moller ELR, Linde JJ, Kofoed KF, Kuhl JT, Procida K, Petersen JK, Havers-Borgersen E, Kober L, Fosbol E. Design and rationale of the EMPagliflozin after Aortic Valve Replacement (EMPAVR) study: A randomized clinical trial. Am Heart J. 2026 Jul;297:107432. doi: 10.1016/j.ahj.2026.107432. Epub 2026 Mar 27.
PubMed 41903746
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPagliflozin After Aortic Valve Replacement - The EMPAVR Study - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06171802
- Acronym / sponsor ID
- EMPAVR / 2023-504731-40-01
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic Valve Stenosis, Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Aortic Valve, Sodium-Glucose Cotransporter-2 inhibitor, SGLT2i, Empagliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 15 Dec 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 study is a randomized, placebo-controlled, and double-blinded trial in patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR). After AVR, patients will be randomized 1:1 to empagliflozin (SGLT2i) or placebo to investigate whether empagliflozin is superior to placebo in reducing left ventricular mass and improve symptoms to 6 months.
Detailed description
In this randomized, placebo-controlled, and double-blinded trial we investigate whether empagliflozin (SGLT2i) is superior to placebo in reducing left ventricular mass and improve symptoms.
All patients with AS who are referred to Rigshospitalet for AVR (both surgical and transcatheter approaches) will be screened for in- and exclusion criteria in the medical record based on the Danish Health Act §46 by the PI, co-PI, or a delegated study nurse. If the patient fulfills the inclusion criteria and none of the exclusions criteria, the patient is invited to participate in the study.
Included patients will be randomized 1:1 in blocks of 2, 4, and 6 patients to either Empagliflozin 10 mg daily or placebo. Point of randomization will be in the hospital when the patients has undergone AVR.
The total treatment period is 6 months with either 10 mg Empagliflozin or placebo. The trial participants will receive conventional treatment, which will be carried out irrespective of the inclusion in the trial in accordance with national guidelines. Routine clinical check-ups irrespective of the trial setup will be performed at 3 months after discharge, and study-outcomes will be assessed at discharge, 3 months, and 6 months (eg. echocardiography). Blood samples (including N-Terminal-proBNP, renal function and electrolytes, hemoglobin and HbA1c) will be part of such routine visits as well as a standardized symptom-scoring tool (KCCQ and NYHA classification). Compliance will be evaluated at 1-, 3- and 6-months. The assessment for 1-month will be per telephone and the assessment at 3- and 6-months will be at the routine clinical check-ups in the outpatient clinic.
The CT scan performed in the planning of the procedure will be used for the baseline assessment (before AVR). An identical exam (CT scan) will be performed at 6 months to assess change in LV mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Active comparator | Drug: EmpagliflozinEmpagliflozin 1 capsule of 10 mg, once daily for six months. |
| Placebo | Placebo comparator | Drug: Placebo1 capsule of placebo, once daily for six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe symptomatic aortic stenosis AND Surgical or transcatheter aortic valve replacement within 14 days
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| EmpagliflozinAlso: Jardiance10 mg empagliflozin daily for six months | Drug | Empagliflozin |
| PlaceboPlacebo capsule once daily for six months | Drug | Placebo |
Primary outcome
Change in left ventricular mass indexed to body surface area
Time frame: 6 months from discharge post-Aortic Valve Replacement
Change in left ventricular mass indexed to body surface area (measured by CT) from pre-Aortic Valve Replacement to 6-months post-Aortic Valve Replacement
10 secondary outcomes
LVESVi
Time frame: 6-months from discharge post-aortic valve replacement
LV GLS (echo)
Time frame: 3- and 6-months from discharge
N-terminal pro B-type natriuretic peptide (NT-proBNP) change
Time frame: 3- and 6-months from discharge
Death and readmission for any non-planned cause
Time frame: 6 months from discharge date (after aortic valve replacement)
Death
Time frame: 6 months from discharge date (after aortic valve replacement)
Readmission for any cause
Time frame: 6 months from discharge date (after aortic valve replacement)
Admission for heart failure
Time frame: 6 months from discharge date (after aortic valve replacement)
Kansas City Cardiomyopathy Questionaire (KCCQ)
Time frame: 6 months from discharge date (after aortic valve replacement)
Quality of Life (QoL) - The Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: 6 months from discharge date (after aortic valve replacement)
New York Heart Association (NYHA) Functional Classification
Time frame: 3- and 6-months from discharge date (after aortic valve replacement)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 41903746Sorensen LM, Reinert MS, Raja AA, de Backer O, Bieliauskas G, Schou M, Jensen J, Moller ELR, Linde JJ, Kofoed KF, Kuhl JT, Procida K, Petersen JK, Havers-Borgersen E, Kober L, Fosbol E. Design and rationale of the EMPagliflozin after Aortic Valve Replacement (EMPAVR) study: A randomized clinical trial. Am Heart J. 2026 Jul;297:107432. doi: 10.1016/j.ahj.2026.107432. Epub 2026 Mar 27.
- Individual participant dataSharing planned: No
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Aortic Valve Stenosis
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.
Emil L. Fosbøl, MD, PhD principal investigator
University Hospital of Copenhagen - Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin in people with Aortic Valve Stenosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 22 May 2026. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in left ventricular mass indexed to body surface area (time frame: 6 months from discharge post-Aortic Valve Replacement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06171802, which also lists 1 linked publication.
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 22 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.