Dapagliflozin After Transcatheter Aortic Valve Implantation

Dapagliflozin After Transcatheter Aortic Valve Implantation

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).

Patients discharged after TAVI, with a history of heart failure (HF) plus depressed left ventricular ejection fraction (LVEF ≤ 40%) or diabetes mellitus (DM) or glomerular filtration rate (GFR) between 25 and 75 ml/min/1.73 m2, will be randomized (1:1) before hospital discharge to receive treatment with dapagliflozin 10 mg/day or no dapagliflozin (no placebo).

Only variables available during routine clinical practice will be collected and there will be no additional tests.

The incidence of clinical events and adherence to the dapagliflozin arm will be documented at 2 time-points (3 ± 1 months and 12 months) by phone calls and review of medical records.

Inclusion Criteria:

• SEVERE AORTIC STENOSIS UNDERWENT TAVI

• PRIOR HEART FAILURE ADMISSION AND ONE OF THE FOLLOWING CRITERIA:

  1. Left ventricular ejection fraction ≤ 40% or
  2. Diabetes mellitus or
  3. Estimated glomerular filtrate rate 25-75 ml/min/1.73 m2

Exclusion Criteria:

• Known allergy or intolerance to SGLT2 inhibitors.
• Concomitant therapy with sulfonylurea or SGLT2 inhibitors..
• Systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg.
• An estimated glomerular filtration rate (GFR) below 25 ml per minute per 1.73 m2.
• Chronic cystitis and/or recurrent urinary tract infections (2 or more in the last year)
• Poor control of diabetes mellitus that requires SGLT-2 inhibitor prescription on discharge according to treating physician judge.
• Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year).
• Pregnant or breast-feeding patients
• Patients participating in other clinical trials.