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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01453608
Recruitment Status : Completed
First Posted : October 18, 2011
Last Update Posted : March 18, 2015
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Vifor Pharma

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Chronic Heart Failure Drug: Ferinject (ferric carboxymaltose) Drug: Placebo (saline) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ferinject (ferric carboxymaltose) Drug: Ferinject (ferric carboxymaltose)
Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0
Placebo Comparator: Placebo (saline) Drug: Placebo (saline)
Subjects will receive Placebo (saline) intravenously on Day 0


Outcome Measures
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Primary Outcome Measures :
  1. Change in six minute walk test from baseline to week 24 [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453608


Locations
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Poland
Clinical Military Hospital
Wroclaw, Poland, 50-891
Russian Federation
State Educational Institution of Higer Professional Education
Ryazan, Russian Federation, 390039
Sponsors and Collaborators
Vifor Pharma
ICON Clinical Research
Investigators
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Principal Investigator: Piotr Ponikowski, MD Cardiology Department - Centre for Heart Disease - Clinical Military Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vifor Pharma
ClinicalTrials.gov Identifier: NCT01453608    
Other Study ID Numbers: FER-CARS-05
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Heart Failure
Anemia, Iron-Deficiency
Iron Deficiencies
Heart Diseases
Cardiovascular Diseases
 Iron Metabolism Disorders
Metabolic Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases