EMPagliflozin After Aortic Valve Replacement

NCT06171802 | Completed Phase 4 DMC

• 1 other identifier: 2023-504731-40-01
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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 ventricular mass and improve symptoms to 6 months.

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve Stenosis; Aortic Valve Replacement; Transcatheter Aortic Valve Implantation; Aortic Valve; Sodium-Glucose Cotransporter-2 inhibitor; SGLT2i; Empagliflozin

Outcome Measures

Primary Outcomes (1)

• 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

  6 months from discharge post-Aortic Valve Replacement

Secondary Outcomes (10)

• LVESVi

  6-months from discharge post-aortic valve replacement

• LV GLS (echo)

  3- and 6-months from discharge

• N-terminal pro B-type natriuretic peptide (NT-proBNP) change

  3- and 6-months from discharge

• Death and readmission for any non-planned cause

  6 months from discharge date (after aortic valve replacement)

• Death

  6 months from discharge date (after aortic valve replacement)

Study Arms (2)

Empagliflozin

ACTIVE COMPARATOR

Empagliflozin 1 capsule of 10 mg, once daily for six months.

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

1 capsule of placebo, once daily for six months

Drug: Placebo

Interventions

Empagliflozin DRUG

10 mg empagliflozin daily for six months

Also known as: Jardiance

Empagliflozin

Placebo DRUG

Placebo capsule once daily for six months

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe symptomatic aortic stenosis AND Surgical or transcatheter aortic valve replacement within 14 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

University Hospital of Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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 Mar 27;297:107432. doi: 10.1016/j.ahj.2026.107432. Online ahead of print.

  PMID: 41903746 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Emil L. Fosbøl, MD, PhD

  University Hospital of Copenhagen - Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: Randomized placebo-controlled

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 15, 2023
• Study Start: February 14, 2024
• Primary Completion: May 8, 2026
• Study Completion: May 18, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)