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

October 13, 2011
May 27, 2014
October 2011
February 2014   (final data collection date for primary outcome measure)
Change in six minute walk test from baseline to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01453608 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Iron Deficiency
  • Chronic Heart Failure
  • Drug: Ferinject (ferric carboxymaltose)
    Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0
  • Drug: Placebo (saline)
    Subjects will receive Placebo (saline) intravenously on Day 0
  • Experimental: Ferinject (ferric carboxymaltose)
    Intervention: Drug: Ferinject (ferric carboxymaltose)
  • Placebo Comparator: Placebo (saline)
    Intervention: Drug: Placebo (saline)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
Not Provided
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Russian Federation
 
NCT01453608
FER-CARS-05
Yes
Vifor Inc.
Vifor Inc.
ICON Clinical Research
Principal Investigator: Piotr Ponikowski, MD Cardiology Department - Centre for Heart Disease - Clinical Military Hospital
Vifor Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP