A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency (CONFIRM-HF)

Vifor

Status and phase

Completed

Phase 4

Conditions

Iron Deficiency

Chronic Heart Failure

Treatments

Drug: Placebo (saline)

Drug: Ferinject (ferric carboxymaltose)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01453608

FER-CARS-05

Details and patient eligibility

About

The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.

Enrollment

304 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 left ventricular ejection fraction
Capable of completing 6 minute walk test
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
Body weight ≤ 35 kg
No other significant cardiac or general disorders that would compromise the ability to give informed consent and/or comply with study procedures