Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure - Full Text View

Sponsors and Collaborators:	National Heart and Lung Institute Wexham Park Hospital 4th Military Hospital, Poland
Information provided by:	National Heart and Lung Institute
ClinicalTrials.gov Identifier:	NCT00125996

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 I Phase II

MedlinePlus related topics: Anemia Dietary Supplements Exercise and Physical Fitness Heart Diseases Heart Failure

Drug Information available for: Sucrose Ferric oxide, saccharated

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Historical Control, Parallel Assignment, Efficacy Study
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

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

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, Wroclaw
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, Berkshire
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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	FERRIC-HF, FERRIC-Hef1, RD010, 131/03L
Study First Received:	August 1, 2005
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00125996 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by National Heart and Lung Institute:

ANAEMIA
Iron Deficiency

Study placed in the following topic categories:

Ferric oxide, saccharated
Heart Failure
Metabolic Diseases
Heart Diseases
Hematinics
Hematologic Diseases

Anemia
Iron Metabolism Disorders
Iron
Metabolic Disorder
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Metabolic Diseases
Hematologic Diseases
Hematinics
Hematologic Agents
Anemia, Hypochromic

Anemia
Iron Metabolism Disorders
Pharmacologic Actions
Anemia, Iron-Deficiency
Ferric oxide, saccharated
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009