Status:
UNKNOWN
Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure
Lead Sponsor:
National Heart and Lung Institute
Collaborating Sponsors:
Wexham Park Hospital
4th Military Clinical Hospital with Polyclinic, Poland
Conditions:
Chronic Heart Failure
Heart Diseases
Eligibility:
All Genders
30-95 years
Phase:
PHASE1
PHASE2
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 ...
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 supplem...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00125996
Start Date
July 1 2004
End Date
February 1 2006
Last Update
August 17 2005
Active Locations (2)
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1
4th Military Clinical Hospital
Weigla 5, Wroclaw, Poland, 50981
2
Wexham Park Hospital
Wexham Park, Slough, Berkshire, United Kingdom, SL2 4HL