Effect of ferric carboxymaltose on exercise capacity in patients with iron deficiency and chronic heart failure

Phase 1

• Conditions: Iron deficiency in patients with chronic heart failure; MedDRA version: 14.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-000603-40-DE
• Lead Sponsor: Vifor (International) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-17
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
2. Reduced exercise capacity
3. Reduced left ventricular ejection fraction
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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96

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 that requires treatment
5. Subject is not using adequate contraceptive precautions during the study
6. No other significant cardiac or general disorder that would compromise participation in the study.
7. Subjects with body weight <35 kg

Study & Design

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