EMPagliflozin After Aortic Valve Replacement (EMPAVR)

Rigshospitalet

Status and phase: Enrolling; Phase 4

Conditions: Aortic Valve Stenosis

Treatments: Drug: Empagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06171802

2023-504731-40-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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205 participants in 2 patient groups, including a placebo group

Empagliflozin

Active Comparator group

Description:

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

Treatment:

Drug: Empagliflozin

Placebo

Placebo Comparator group

Description:

1 capsule of placebo, once daily for six months

Treatment:

Drug: Placebo