Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696185
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2020-12-30
Brief Title:
Dapagliflozin After Transcatheter Aortic Valve Implantation
Sponsor:
Spanish Society of Cardiology
Organization:
Spanish Society of Cardiology
Study Overview
Official Title:
Dapagliflozin After Transcatheter Aortic Valve Implantation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DapaTAVI
Brief 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 mlmin173 m2 will be randomized 11 before hospital discharge to receive treatment with dapagliflozin 10 mgday 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None