Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure
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|ClinicalTrials.gov Identifier: NCT00125996|
Recruitment Status : Unknown
Verified January 2005 by National Heart and Lung Institute.
Recruitment status was: Recruiting
First Posted : August 2, 2005
Last Update Posted : August 17, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure Heart Diseases Anemia, Iron-Deficiency||Drug: Venofer (intravenous iron sucrose)||Phase 1 Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||July 2004|
|Estimated Study Completion Date :||February 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|