NCT00125996

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (planned)
• Sponsor: National Heart and Lung Institute · Academic / Other
• Sex: All
• Age: 30 Years – 95 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Venofer (intravenous iron sucrose)

Timeline

• Start date: 2004-07-01
• Completion: 2006-02-01
• First posted: 2005-08-02
• Last updated: 2005-08-17

Locations

2 sites across 2 countries: Poland, United Kingdom