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Dapagliflozin After Transcatheter Aortic Valve Implantation — DapaTAVI  

Aortic Stenosis Clinical Trial

Official title:
Dapagliflozin After Transcatheter Aortic Valve Implantation

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04696185
Study type Interventional
Source Spanish Society of Cardiology
Contact
Status Active, not recruiting
Phase Phase 4
Start date January 27, 2021
Completion date December 31, 2024
View Details
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