Clinical trial NCT06171802: EMPagliflozin After Aortic Valve Replacement
Official title: EMPagliflozin After Aortic Valve Replacement - the EMPAVR Study - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis
Aortic Valve Replacement
Transcatheter Aortic Valve Implantation
Aortic Valve
Sodium-Glucose Cotransporter-2 inhibitor
SGLT2i
Empagliflozin
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in left ventricular mass indexed to body surface area
timeFrame: 6 months from discharge post-Aortic Valve Replacement
Secondary outcomes:
measure: LVESVi
timeFrame: 6-months from discharge post-aortic valve replacement
measure: LV GLS (echo)
timeFrame: 3- and 6-months from discharge
measure: N-terminal pro B-type natriuretic peptide (NT-proBNP) change
timeFrame: 3- and 6-months from discharge
measure: Death and readmission for any non-planned cause
timeFrame: 6 months from discharge date (after aortic valve replacement)
measure: Death
timeFrame: 6 months from discharge date (after aortic valve replacement)
measure: Readmission for any cause
timeFrame: 6 months from discharge date (after aortic valve replacement)
measure: Admission for heart failure
timeFrame: 6 months from discharge date (after aortic valve replacement)
measure: Kansas City Cardiomyopathy Questionaire (KCCQ)
timeFrame: 6 months from discharge date (after aortic valve replacement)
measure: Quality of Life (QoL) - The Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: 6 months from discharge date (after aortic valve replacement)
measure: New York Heart Association (NYHA) Functional Classification
timeFrame: 3- and 6-months from discharge date (after aortic valve replacement)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital of Copenhagen, Rigshospitalet
Study officials:
affiliation: University Hospital of Copenhagen - Rigshospitalet
name: Emil L. Fosbøl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: