Dapagliflozin After Transcatheter Aortic Valve Implantation

Sponsor
Spanish Society of Cardiology
Study ID
NCT04696185
Phase
PHASE4
Status
Completed

Conditions

  • Aortic Stenosis
  • Transcatether Aortic Valve Implantation

Eligibility Criteria

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

Interventions

Study Details

Pragmatic, controlled, prospective, randomized, open-label (open-label), evaluator-blind clinical trial (PROBE design) that will analyze the benefits of dapagliflozin treatment in patients with severe aortic stenosis discharged after implantation of an aortic valve prosthesis transcatheter (TAVI).

Key Dates

Start date
Jan 27, 2021
Status verified
Jan 2025
Primary completion
Dec 29, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
1,257 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg
  • No Intervention: Standard care
    No SGLT-2 inhibitor therapy with dapagliflozin

Primary Outcome Measure

Incidence rate of the composite of all-cause mortality or worsening heart failure (HF) [ Time Frame: 1 year ]

Related Studies