Dapagliflozin After Transcatheter Aortic Valve Implantation (DapaTAVI)

Spanish Society of Cardiology

Status and phase: Completed; Phase 4

Conditions: Transcatether Aortic Valve Implantation; Aortic Stenosis

Treatments: Drug: Dapagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04696185

SEC-DAPATAVI-2020

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1,257 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,257 participants in 2 patient groups

Dapagliflozin

Active Comparator group

Description:

Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg

Treatment:

Drug: Dapagliflozin 10 MG

Standard care

No Intervention group

Description:

No SGLT-2 inhibitor therapy with dapagliflozin