Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386126
Status:
UNKNOWN
Last Update Posted:
2006-10-11
First Post:
2006-10-06
Brief Title:
Iron Supplementation in Heart Failure Patients With Anemia The IRON-HF Study
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia The IRON-HF Study
Status:
UNKNOWN
Status Verified Date:
2006-08
Last Known Status:
RECRUITING
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:
Anemia has been demonstrated to be a common finding in patients with heart failure HF Previous studies in hospitalized patients with HF have found a prevalence of anemia ranging from 15 to 63 More importantly anemic patients with HF have increased morbidity and mortality The mechanisms underlying anemia in HF are multifactorial involving mild to moderate forms of anemia of chronic disease and ferropenic anemia The clinical impact of iron supplementation in HF patients who have a relatively preserved renal function and either chronic disease anemia ferropenic anemia or both remains largely unknown The route of iron administration that could be most clinically effective is also unclear Thus the primary aim of the IRON-HF study is to assess the effects of iron supplementation alone IV or PO on parameters of functional capacity in HF patients with anemia with decreased availability of iron
Detailed Description:
The IRON-HF study is an investigator initiated multicenter prospectively designedrandomized double-blind placebo controlled clinical trial
RandomizationEach of the eight participating centers will randomize patients by telephone contact with the randomization center at Hospital de Clínicas de Porto Alegre The randomization system will be based on a computerized table of random numbers and performed in blocks of three per participating center
BlindingEach participating center will elect a third party blind individual usually a RN who will open the allocated medication box prepare iron sucrose infusions or saline and administer to patients in opaque devices Both patient and attending physicians andor nurses will be blind to allocated therapy Oral medications and oral placebo will be identical in all aspects
RandomizationEach of the eight participating centers will randomize patients by telephone contact with the randomization center at Hospital de Clínicas de Porto Alegre The randomization system will be based on a computerized table of random numbers and performed in blocks of three per participating center
BlindingEach participating center will elect a third party blind individual usually a RN who will open the allocated medication box prepare iron sucrose infusions or saline and administer to patients in opaque devices Both patient and attending physicians andor nurses will be blind to allocated therapy Oral medications and oral placebo will be identical in all aspects
Study Oversight
Has Oversight DMC:
None
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?:
None