Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-31 @ 8:39 AM
Study NCT ID:
NCT01925703
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2013-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Status:
COMPLETED
Status Verified Date:
2014-05
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:
None
Brief Summary:
Intravenous iron replacement has been shown to benefit patients with heart failure and iron deficiency, but the weekly outpatient regimens studied to date are impractical for many patients. Our purpose is to evaluate the short-term effects and safety of an accelerated intravenous iron regimen in hospitalized patients with these two conditions.
Detailed Description:
The purpose of this pilot investigation is to evaluate the short-term hematologic effects and safety of an accelerated intravenous iron regimen in patients with heart failure and iron deficiency. Recent investigations have demonstrated improved clinical outcomes with the use of intravenous iron therapy in this patient population, but a weekly regimen administered to ambulatory patients may be inconvenient, impractical, and associated with less than optimal adherence rates for many patients, especially those with reduced functional capacity. The heart failure population is characterized by frequent hospitalizations, which would make an accelerated inpatient regimen a convenient and attractive option for improving heart failure symptoms, exercise tolerance, and quality of life. Accelerated regimens have been demonstrated as being both safe and effective in other patient populations, but no studies to date have evaluated this strategy in hospitalized patients with heart failure.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: