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Completed

NCT Number: NCT01453608

A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

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.

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Key information

Conditions

Iron Deficiency Chronic Heart Failure Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Military Hospital, Wroclaw, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferinject (ferric carboxymaltose)

Drug

Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0

Placebo (saline)

Drug

Subjects will receive Placebo (saline) intravenously on Day 0

Primary outcomes

  1. Change in six minute walk test from baseline to week 24

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Vifor Pharma

Industry

Collaborators

  • ICON Clinical Research

Registry information

Official study title

A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

Acronym: CONFIRM-HF

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Oct 18, 2011
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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