Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure
Recruitment status was: Recruiting
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.
|Chronic Heart Failure Heart Diseases Anemia, Iron-Deficiency||Drug: Venofer (intravenous iron sucrose)||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomised Controlled Study to Assess the Acute and Chronic Effects of Intravenous Iron Supplementation in Anaemic and Non-Anaemic Iron Deficient Patients With Chronic Heart Failure|
- Change 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
|Study Start Date:||July 2004|
|Estimated Study Completion Date:||February 2006|
Study Phase and Design:
Prospective two-centre, randomized, controlled, open-label, observer-blinded, parallel-group study
To evaluate the effect of intravenous (IV) iron supplementation on exercise tolerance, as determined by peak VO2.
- 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.
42 subjects (28 IV iron, 14 placebo); 50% anaemic and 50% non-anaemic
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125996
|Contact: Darlington O Okonko, BSc, MRCP||02073518700||D.OKONKO@IC.AC.UK|
|4th Military Clinical Hospital||Recruiting|
|Weigla 5, Wroclaw, Poland, 50981|
|Contact: Piotr Ponikowski, MD PHD (48) 717660250 email@example.com|
|Principal Investigator: Piotr Ponikowski, MD PHD|
|Wexham Park Hospital||Recruiting|
|Wexham Park, Slough, Berkshire, United Kingdom, SL2 4HL|
|Contact: Constantinous Missouris, MD (44)01753 634680 firstname.lastname@example.org|
|Contact: Amit K Mandall, MRCP (44)01753 634680 email@example.com|
|Principal Investigator: Constantinous Missouris, MD|
|Principal Investigator:||Philip A Poole-Wilson, MD,FRCP||NHLI, Imperial College School of Medicine|