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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01453608
First received: October 13, 2011
Last updated: May 27, 2014
Last verified: May 2014
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2011
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01453608     History of Changes
Other Study ID Numbers: FER-CARS-05
Study First Received: October 13, 2011
Last Updated: May 27, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Austria: Ethikkommission
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Ireland: Ministry of Health
Ireland: Medical Ethics Research Committee
Italy: Ethics Committee
Italy: Ministry of Health
Poland: Ethics Committee
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Portugal: Ethics Committee for Clinical Research
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
Spain: Ethics Committee
Spain: Ministry of Health
Sweden: Medical Products Agency
Sweden: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014