Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study
Recruitment status was Recruiting
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.
Drug: Iron Sucrose IV 200mg, once a week, for 5 weeks
Drug: Ferrous sulfate 200mg PO TID, for 8 weeks
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
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|