This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: * Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. * IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.
Study Phase and Design: Prospective two-centre, randomized, controlled, open-label, observer-blinded, parallel-group study Primary Objective: To evaluate the effect of intravenous (IV) iron supplementation on exercise tolerance, as determined by peak VO2. Secondary Objectives: * To evaluate the effects of IV iron supplementation on exercise duration, left ventricular (LV) structure and function, symptom status (NYHA class, Minnesota Living with Heart Failure Questionnaire \[MLHFQ\], and subjective fatigue score), and haematological and biochemical (haemoglobin \[Hb\], haematocrit \[Hct\], iron status, N-BNP, cytokines and oxidative stress) indices. * To evaluate the safety profile of IV iron in subjects with moderate to severe CHF. Sample Size: 42 subjects (28 IV iron, 14 placebo); 50% anaemic and 50% non-anaemic
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
42
4th Military Clinical Hospital
Weigla 5, Wroclaw, Poland
RECRUITINGWexham Park Hospital
Wexham Park, Slough, Berkshire, United Kingdom
RECRUITINGChange in peak VO2 from baseline to week 18
Change in cardiopulmonary exercise duration from baseline to week 18
Change in distance walked during 6 minute walk test from baseline to end of repletion phase in treatment group or week 8 in control group, and week 18
Change in left ventricular (LV) systolic and diastolic dimensions, and function from baseline to week 18
Change in symptom status (New York Heart Association [NYHA] class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], visual analogue fatigue scale) from baseline to week 1,week 8, and week 18
Change in haematological and biochemical indices (Hb, Hct, iron status, N-BNP, cytokines and oxidative stress) from baseline to week 18
Number and incidence of adverse events
Changes in liver function tests and renal function tests
Changes in vital parameters
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