NCT04696185

Dapagliflozin After Transcatheter Aortic Valve Implantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,257 (actual)
• Sponsor: Spanish Society of Cardiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Aortic Stenosis
• Transcatether Aortic Valve Implantation

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10 MG	Dapagliflozin 10 mg (daily oral dose)

Timeline

• Start date: 2021-01-27
• Primary completion: 2024-12-29
• Completion: 2024-12-30
• First posted: 2021-01-06
• Last updated: 2025-01-10

Locations

40 sites across 1 country: Spain