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

NCT ID: NCT00125996

Last Updated: 2005-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2006-02-28

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.

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

Conditions

Chronic Heart Failure; Heart Diseases; Anemia, Iron-Deficiency

Keywords

ANAEMIA; Iron Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Venofer (intravenous iron sucrose)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wexham Park Hospital

OTHER

Sponsor Role: collaborator

4th Military Clinical Hospital with Polyclinic, Poland

OTHER

Sponsor Role: collaborator

National Heart and Lung Institute

OTHER

Sponsor Role: lead

Principal Investigators

Philip A Poole-Wilson, MD,FRCP

Role: PRINCIPAL_INVESTIGATOR

NHLI, Imperial College School of Medicine

Locations

4th Military Clinical Hospital

Weigla 5, Wroclaw, Poland

Site Status: RECRUITING

Wexham Park Hospital

Wexham Park, Slough, Berkshire, United Kingdom

Site Status: RECRUITING

Countries

Poland; United Kingdom

Central Contacts

Darlington O Okonko, BSc, MRCP

Role: CONTACT

Phone: 02073518700

Email: D.OKONKO@IC.AC.UK

Facility Contacts

Piotr Ponikowski, MD PHD

Role: primary

Constantinous Missouris, MD

Role: primary

Amit K Mandall, MRCP

Role: backup

References

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. doi: 10.1016/j.jacc.2007.09.036.

Reference Type: DERIVED

PMID: 18191732 (View on PubMed)

Other Identifiers

FERRIC-Hef1

Identifier Type: -

Identifier Source: secondary_id

RD010

Identifier Type: -

Identifier Source: secondary_id

131/03L

Identifier Type: -

Identifier Source: secondary_id

FERRIC-HF

Identifier Type: -

Identifier Source: org_study_id