Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure

Phase 3

Completed

• Conditions: Chronic Heart Failure; Iron Deficiency
• Interventions: Drug: Ferinject (ferric carboxymaltose); Other: Standard of Care

• Registration Number: NCT01394562
• Lead Sponsor: Vifor Pharma

Brief Summary

The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-14
• Status Verified: 2015-12
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
• Reduced exercise capacity
• Reduced left ventricular ejection fraction
• At least 18 years of age and with written informed consent prior to any study specific procedures

Exclusion Criteria

• Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation
• Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
• Chronic liver disease and/or elevated liver enzymes
• Vitamin B12 and/or serum folate deficiency
• Subject is not using adequate contraceptive precautions during the study
• No other significant cardiac or general disorder that would compromise participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferinject (ferric carboxymaltose)	Ferinject (ferric carboxymaltose)	-
Standard of Care	Standard of Care	Standard of care. IV iron is not permitted

Primary Outcome Measures

Name	Time	Method
Change in Peak VO2 (mL/kg/min) from baseline to Week 24	Week 24

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands