Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2005 by National Heart and Lung Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Wexham Park Hospital
4th Military Hospital, Poland
Information provided by:
National Heart and Lung Institute
ClinicalTrials.gov Identifier:
NCT00125996
First received: August 1, 2005
Last updated: August 16, 2005
Last verified: January 2005

August 1, 2005
August 16, 2005
July 2004
Not Provided
Change in peak VO2 from baseline to week 18
Same as current
Complete list of historical versions of study NCT00125996 on ClinicalTrials.gov Archive Site
  • 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
  • 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 LV systolic and diastolic dimensions, and function from baseline to week 18
  • Change in symptom status (NYHA class, 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
Not Provided
Not Provided
 
Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure
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

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Chronic Heart Failure
  • Heart Diseases
  • Anemia, Iron-Deficiency
Drug: Venofer (intravenous iron sucrose)
Not Provided
Okonko DO, Grzeslo A, Witkowski T, Mandal AK, Slater RM, Roughton M, Foldes G, Thum T, Majda J, Banasiak W, Missouris CG, Poole-Wilson PA, Anker SD, Ponikowski P. 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. J Am Coll Cardiol. 2008 Jan 15;51(2):103-12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
February 2006
Not Provided

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
Both
30 Years to 95 Years
No
Contact: Darlington O Okonko, BSc, MRCP 02073518700 D.OKONKO@IC.AC.UK
Poland,   United Kingdom
 
NCT00125996
FERRIC-HF, FERRIC-Hef1, RD010, 131/03L
Not Provided
Not Provided
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
National Heart and Lung Institute
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP