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
4 other identifiers
interventional
42
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2004
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 1, 2005
CompletedFirst Posted
Study publicly available on registry
August 2, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedAugust 17, 2005
January 1, 2005
August 1, 2005
August 16, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in peak VO2 from baseline to week 18
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- ≥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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Heart and Lung Institutelead
- Wexham Park Hospitalcollaborator
- 4th Military Clinical Hospital with Polyclinic, Polandcollaborator
Study Sites (2)
4th Military Clinical Hospital
Weigla 5, Wroclaw, 50981, Poland
Wexham Park Hospital
Wexham Park, Slough, Berkshire, SL2 4HL, United Kingdom
Related Publications (1)
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.
PMID: 18191732DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip A Poole-Wilson, MD,FRCP
NHLI, Imperial College School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 1, 2005
First Posted
August 2, 2005
Study Start
July 1, 2004
Study Completion
February 1, 2006
Last Updated
August 17, 2005
Record last verified: 2005-01