A study to compare the use of ferric carboxymaltose with placebo in patients with chronic heart failure and iron deficiency

• Conditions: Iron deficiency in patients with chronic heart failure; MedDRA version: 14.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001695-19-ES
• Lead Sponsor: Vifor (International) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-28
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
2. Reduced left ventricular ejection fraction
3. Capable of completing 6 minute walk test (6MWT)
4. At least 18 years of age and with written informed consent prior to any study specific procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 132
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 198

Exclusion Criteria

1. Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or blood transfusion in previous 6 weeks prior to randomisation.
2. Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
3.Chronic liver disease and/or elevated liver enzymes
4. Vitamin B12 and/or serum folate deficiency
5. Subject is not using adequate contraceptive precautions during the study
6. Body weight ?35 kg
7. No other significant cardiac or general disorders that would comprise the ability to give informed consent and/or comply with study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified