Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-03-08
First Post:
2021-03-02
Brief Title:
Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
Sponsor:
Hospital de Santa Cruz Portugal
Organization:
Hospital de Santa Cruz Portugal
Study Overview
Official Title:
A Randomized Clinical Trial of Intravenous Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-03
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:
INERTIA
Brief Summary:
The INERTIA trial is a multicenter double-blinded randomized trial of intravenous iron supplementation in patients with severe aortic stenosis and iron deficiency undergoing TAVI or SAVR The primary endpoint is the time to HF hospital admission or cardiovascular death Secondary endpoints will assess quality of life indicators and functional capacity at 6 months
Detailed Description:
None
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