Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study
Recruitment status was: Recruiting
|Heart Failure Anemia||Drug: Iron Sucrose IV 200mg, once a week, for 5 weeks Drug: Ferrous sulfate 200mg PO TID, for 8 weeks||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study|
- The primary endpoint of the IRON-HF study is to assess the impact of iron supplementation alone (IV or PO) on changes in oxygen maximal consumption (peak VO2) assessed by ergospirometry over a 3-month follow-up period.
- New York Heart Association (NYHA) functional class
- BNP (B-type natriuretic peptide) levels
- Quality of life using the Living with Heart Failure Minnesota Questionnaire
- Left ventricular ejection fraction (LVEF) as assessed by the bi-planar modified Simpson method in two-dimensional echocardiography
- Renal function as assessed by the serum levels of creatinine
- Incidence of hospitalizations due to HF
- Incidence of adverse events (drug tolerance).
|Study Start Date:||August 2006|
The IRON-HF study is an investigator initiated, multicenter, prospectively designed,randomized, double-blind, placebo controlled clinical trial.
Randomization:Each 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.
Blinding:Each 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 and/or nurses will be blind to allocated therapy. Oral medications and oral placebo will be identical in all aspects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386126
|Contact: Luis Beck-da-Silva, MD||55 51 21018657 ext firstname.lastname@example.org|
|Contact: Michelle C Assis, RN||55 51 21018657 ext email@example.com|
|Cardiovascular Division, Hospital de Clínicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil, 90035-003|
|Contact: Luis Beck-da-Silva, MD 55 5121018344 ext 8344 firstname.lastname@example.org|
|Study Chair:||Nadine Clausell, MD||Hospital de Clínicas de Porto Alegre|