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Sponsored by: |
Hospital de Clinicas de Porto Alegre |
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Information provided by: | Hospital de Clinicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT00386126 |
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.
Condition | Intervention | Phase |
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Heart Failure Anemia |
Drug: Iron Sucrose IV 200mg, once a week, for 5 weeks Drug: Ferrous sulfate 200mg PO TID, for 8 weeks |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study |
Estimated Enrollment: | 117 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Luis Beck-da-Silva, MD | 55 51 21018657 ext 8657 | lbneto@hcpa.ufrgs.br |
Contact: Michelle C Assis, RN | 55 51 21018657 ext 8657 | mcassis@hcpa.ufrgs.br |
Brazil, RS | |
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 lbneto@hcpa.ufrgs.br |
Study Chair: | Nadine Clausell, MD | Hospital de Clínicas de Porto Alegre |
Study ID Numbers: | HCPA 06-115 |
Study First Received: | October 6, 2006 |
Last Updated: | October 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00386126 |
Health Authority: | Brazil: Ministry of Health |
Heart Failure Anemia Treatment |
Ferric oxide, saccharated Heart Failure Heart Diseases |
Hematologic Diseases Anemia Iron |
Hematinics Growth Substances Therapeutic Uses Physiological Effects of Drugs Hematologic Agents |
Trace Elements Cardiovascular Diseases Micronutrients Pharmacologic Actions |