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

• Status: Unknown status
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart and Lung Institute
• Collaborators: 4th Military Hospital; 4th Military Hospital, Poland; Wexham Park Hospital
• Treatments: Ferric Oxide, Saccharated; Iron

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