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

Last updated: May 16, 2017
Sponsor: Vifor (International) Inc.
Overall Status: Completed

Phase

3

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT01394562
FER-CARS-04
2011-000603-40
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) onoptimal 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 specificprocedures

Exclusion

Exclusion Criteria:

  • Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusionin 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 participationin the study

Study Design

Total Participants: 174
Study Start date:
July 01, 2011
Estimated Completion Date:
May 31, 2016

Connect with a study center

  • University Medical Center Groningen

    Groningen, 9700 RB
    Netherlands

    Site Not Available

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