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
  Purpose

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 Intervention Phase
Chronic Heart Failure
Heart Diseases
Anemia, Iron-Deficiency
Drug: Venofer (intravenous iron sucrose)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by National Heart and Lung Institute:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 42
Study Start Date: July 2004
Estimated Study Completion Date: February 2006
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

  Eligibility

Ages Eligible for Study:   30 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125996

Contacts
Contact: Darlington O Okonko, BSc, MRCP 02073518700 D.OKONKO@IC.AC.UK

Locations
Poland
4th Military Clinical Hospital Recruiting
Weigla 5, Wroclaw, Poland, 50981
Contact: Piotr Ponikowski, MD PHD    (48) 717660250    piotrponikowski@hotmail.com   
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    cmissouris@btopenworld.com   
Contact: Amit K Mandall, MRCP    (44)01753 634680    akjm@mac.com   
Principal Investigator: Constantinous Missouris, MD         
Sponsors and Collaborators
National Heart and Lung Institute
Wexham Park Hospital
4th Military Hospital, Poland
Investigators
Principal Investigator: Philip A Poole-Wilson, MD,FRCP NHLI, Imperial College School of Medicine
  More Information

No publications provided by National Heart and Lung Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00125996     History of Changes
Other Study ID Numbers: FERRIC-HF, FERRIC-Hef1, RD010, 131/03L
Study First Received: August 1, 2005
Last Updated: August 16, 2005
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by National Heart and Lung Institute:
ANAEMIA
Iron Deficiency

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

ClinicalTrials.gov processed this record on August 19, 2014