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

NCT00125996 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2005-08-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Venofer (intravenous iron sucrose)

Sponsors & Collaborators

  • Wexham Park Hospital

    collaborator OTHER
  • 4th Military Clinical Hospital with Polyclinic, Poland

    collaborator OTHER
  • National Heart and Lung Institute

    lead OTHER

Principal Investigators

  • Philip A Poole-Wilson, MD,FRCP · NHLI, Imperial College School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Completion
2006-02-28

Countries

  • Poland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00125996 on ClinicalTrials.gov