Document Detail


Effect of intravenous iron sucrose on exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure and iron deficiency FERRIC-HF: a randomized, controlled, observer-blinded trial.
MedLine Citation:
PMID:  18191732     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: We tested the hypothesis that intravenous iron improves exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure (CHF) and iron deficiency. BACKGROUND: Anemia is common in heart failure. Iron metabolism is disturbed, and administration of iron might improve both symptoms and exercise tolerance. METHODS: We randomized 35 patients with CHF (age 64 +/- 13 years, peak oxygen consumption [pVO2] 14.0 +/- 2.7 ml/kg/min) to 16 weeks of intravenous iron (200 mg weekly until ferritin >500 ng/ml, 200 mg monthly thereafter) or no treatment in a 2:1 ratio. Ferritin was required to be <100 ng/ml or ferritin 100 to 300 ng/ml with transferrin saturation <20%. Patients were stratified according to hemoglobin levels (<12.5 g/dl [anemic group] vs. 12.5 to 14.5 g/dl [nonanemic group]). The observer-blinded primary end point was the change in absolute pVO2. RESULTS: The difference (95% confidence interval [CI]) in the mean changes from baseline to end of study between the iron and control groups was 273 (151 to 396) ng/ml for ferritin (p < 0.0001), 0.1 (-0.8 to 0.9) g/dl for hemoglobin (p = 0.9), 96 (-12 to 205) ml/min for absolute pVO2 (p = 0.08), 2.2 (0.5 to 4.0) ml/kg/min for pVO2/kg (p = 0.01), 60 (-6 to 126) s for treadmill exercise duration (p = 0.08), -0.6 (-0.9 to -0.2) for New York Heart Association (NYHA) functional class (p = 0.007), and 1.7 (0.7 to 2.6) for patient global assessment (p = 0.002). In anemic patients (n = 18), the difference (95% CI) was 204 (31 to 378) ml/min for absolute pVO2 (p = 0.02), and 3.9 (1.1 to 6.8) ml/kg/min for pVO2/kg (p = 0.01). In nonanemic patients, NYHA functional class improved (p = 0.06). Adverse events were similar. CONCLUSIONS: Intravenous iron loading improved exercise capacity and symptoms in patients with CHF and evidence of abnormal iron metabolism. Benefits were more evident in anemic patients. (Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure; http://www.clinicaltrials.gov/ct/show/NCT00125996; NCT00125996).
Authors:
Darlington O Okonko; Agnieszka Grzeslo; Tomasz Witkowski; Amit K J Mandal; Robert M Slater; Michael Roughton; Gabor Foldes; Thomas Thum; Jacek Majda; Waldemar Banasiak; Constantinos G Missouris; Philip A Poole-Wilson; Stefan D Anker; Piotr Ponikowski
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  51     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2008 Jan 
Date Detail:
Created Date:  2008-01-14     Completed Date:  2008-02-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  103-12     Citation Subset:  AIM; IM    
Affiliation:
Clinical Cardiology, NHLI, Imperial College London, London, United Kingdom. d.okonko@imperial.ac.uk
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00125996
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MeSH Terms
Descriptor/Qualifier:
Aged
Analysis of Variance
Anemia, Iron-Deficiency / complications,  diagnosis,  drug therapy*,  mortality
Chronic Disease
Confidence Intervals
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Exercise Tolerance / drug effects*
Female
Ferric Compounds / administration & dosage*
Follow-Up Studies
Heart Failure / complications,  diagnosis,  drug therapy*,  mortality
Humans
Infusions, Intravenous
Male
Middle Aged
Oxygen Consumption / drug effects*,  physiology
Probability
Prospective Studies
Reference Values
Risk Assessment
Survival Rate
Treatment Outcome
Chemical
Reg. No./Substance:
0/Ferric Compounds

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