EMPagliflozin After Aortic Valve Replacement

Sponsor
Rigshospitalet, Denmark
Study ID
NCT06171802
Phase
PHASE4
Status
Completed

Conditions

  • Aortic Valve Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    10 mg empagliflozin daily for six months
  • Placebo — DRUG
    Placebo capsule once daily for six months

Study Details

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.

Key Dates

Start date
Feb 14, 2024
Status verified
May 2026
Primary completion
May 8, 2026
Completion
May 18, 2026

Study Design

Enrollment
206 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Empagliflozin
    Empagliflozin 1 capsule of 10 mg, once daily for six months.
  • Placebo Comparator: Placebo
    1 capsule of placebo, once daily for six months

Primary Outcome Measure

Change in left ventricular mass indexed to body surface area [ Time Frame: 6 months from discharge post-Aortic Valve Replacement ]

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