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Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure (EFFECT-HF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394562
First Posted: July 14, 2011
Last Update Posted: May 18, 2017
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.
Information provided by (Responsible Party):
Vifor Inc.
July 12, 2011
July 14, 2011
May 18, 2017
July 2011
May 2016   (Final data collection date for primary outcome measure)
Change in Peak VO2 (mL/kg/min) from baseline to Week 24 [ Time Frame: Week 24 ]
Same as current
Complete list of historical versions of study NCT01394562 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure
Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients With Iron Deficiency
The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Iron Deficiency
  • Chronic Heart Failure
  • Drug: Ferinject (ferric carboxymaltose)
    Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12
  • Other: Standard of Care
    Subjects randomised to Standard of Care may receive oral iron at Investigator's discretion however patients will not be permitted to receive IV iron
  • Experimental: Ferinject (ferric carboxymaltose)
    Intervention: Drug: Ferinject (ferric carboxymaltose)
  • Standard of Care
    Standard of care. IV iron is not permitted
    Intervention: Other: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
May 2016
May 2016   (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 exercise capacity
  • Reduced left ventricular ejection fraction
  • 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
  • No other significant cardiac or general disorder that would compromise participation in the study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01394562
FER-CARS-04
2011-000603-40 ( EudraCT Number )
Yes
Not Provided
Not Provided
Vifor Inc.
Vifor Inc.
Not Provided
Principal Investigator: Dirk van Veldhuisen, MD University Medical Center Groningen
Vifor Inc.
December 2015

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