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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01453608
First Posted: October 18, 2011
Last Update Posted: March 18, 2015
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.
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Vifor Inc.
  Purpose
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 Intervention Phase
Iron Deficiency Chronic Heart Failure Drug: Ferinject (ferric carboxymaltose) Drug: Placebo (saline) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

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

Enrollment: 304
Study Start Date: October 2011
Study Completion Date: January 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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 Inc.
ICON Clinical Research
Investigators
Principal Investigator: Piotr Ponikowski, MD Cardiology Department - Centre for Heart Disease - Clinical Military Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01453608     History of Changes
Other Study ID Numbers: FER-CARS-05
First Submitted: October 13, 2011
First Posted: October 18, 2011
Last Update Posted: March 18, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics