Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure (EFFECT-HF)

Vifor

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency; Chronic Heart Failure

Treatments: Other: Standard of Care; Drug: Ferinject (ferric carboxymaltose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01394562

2011-000603-40 (EudraCT Number)

FER-CARS-04

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Ferinject (ferric carboxymaltose)

Experimental group

Treatment:

Drug: Ferinject (ferric carboxymaltose)

Standard of Care

Other group

Description:

Standard of care. IV iron is not permitted

Treatment:

Other: Standard of Care