Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Wexham Park Hospital
4th Military Hospital, Poland
Information provided by:
National Heart and Lung Institute

Brief Summary:

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

Detailed Description:

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  (Clinical Trial)
Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : July 2004
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron
U.S. FDA Resources

Primary Outcome Measures :
  1. Change in peak VO2 from baseline to week 18

Secondary Outcome Measures :
  1. Change in cardiopulmonary exercise duration from baseline to week 18
  2. 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
  3. Change in left ventricular (LV) systolic and diastolic dimensions, and function from baseline to week 18
  4. 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
  5. Change in haematological and biochemical indices (Hb, Hct, iron status, N-BNP, cytokines and oxidative stress) from baseline to week 18
  6. Number and incidence of adverse events
  7. Changes in liver function tests and renal function tests
  8. Changes in vital parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ≥21 years of age and have signed written informed consent
  • Stable symptomatic CHF; NYHA III/IV and left ventricular ejection fraction (LVEF) ≤40%, or if NYHA II then LVEF must be ≤35%, as assessed within last 6 months using echocardiographic or magnetic resonance imaging techniques.
  • On optimal conventional therapy for at least 4 weeks prior to recruitment and without dose changes for at least 2 weeks.
  • Peak VO2 ≤ 18 ml/kg/min on modified Naughton protocol cardiopulmonary exercise testing.
  • Mean of the 2 screening Hb concentrations (week-2 and week-1) < 12.5 g/dl (anaemic group, 50% of study population) or 12.5-14.0 g/dl (non-anaemic group, 50% of study population).
  • Ferritin <100 µg/l or 100-300 µg/l with TSAT <20%.
  • Normal red cell folate and vitamin B12 status (according to local lab reference range).
  • Resting blood pressure ≤160/100 mmHg.

Exclusion Criteria:

  • History of acquired iron overload; known haemochromatosis or first relatives with haemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
  • Known hypersensitivity to parental iron preparations.
  • Known active infection, bleeding, malignancy and haemolytic anaemia.
  • History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the upper limit of the normal range; chronic lung disease; myelodysplastic disorder; and known HIV/AIDS disease.
  • Recipient of immunosuppressive therapy or renal dialysis.
  • History of erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days.
  • Unstable angina pectoris, as judged by the investigator; severe uncorrected valvular disease or left ventricular outflow obstruction; obstructive cardiomyopathy; uncontrolled fast atrial fibrillation or flutter (heart rate >110 beats per minute [bpm]); uncontrolled symptomatic brady- or tachyarrhythmias.
  • Musculoskeletal limitation that, in the judgement of the investigator, would impair cardiopulmonary exercise testing.
  • Pregnant or breast-feeding
  • Inability to comprehend study protocol
  • Parallel participation in another clinical trial

Information from the National Library of Medicine

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 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   
Principal Investigator: Piotr Ponikowski, MD PHD         
United Kingdom
Wexham Park Hospital Recruiting
Wexham Park, Slough, Berkshire, United Kingdom, SL2 4HL
Contact: Constantinous Missouris, MD    (44)01753 634680   
Contact: Amit K Mandall, MRCP    (44)01753 634680   
Principal Investigator: Constantinous Missouris, MD         
Sponsors and Collaborators
National Heart and Lung Institute
Wexham Park Hospital
4th Military Hospital, Poland
Principal Investigator: Philip A Poole-Wilson, MD,FRCP NHLI, Imperial College School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00125996     History of Changes
Other Study ID Numbers: FERRIC-HF
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: August 17, 2005
Last Verified: January 2005

Keywords provided by National Heart and Lung Institute:
Iron Deficiency

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Anemia, Iron-Deficiency
Cardiovascular Diseases
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric oxide, saccharated
Trace Elements
Growth Substances
Physiological Effects of Drugs