EMPagliflozin After Aortic Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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

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Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo-controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blinded trial

Study Groups

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Empagliflozin

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

Group Type ACTIVE_COMPARATOR

Empagliflozin

Intervention Type DRUG

10 mg empagliflozin daily for six months

Placebo

1 capsule of placebo, once daily for six months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule once daily for six months

Interventions

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Empagliflozin

10 mg empagliflozin daily for six months

Intervention Type DRUG

Placebo

Placebo capsule once daily for six months

Intervention Type DRUG

Other Intervention Names

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Jardiance

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No