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

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ClinicalTrials.gov Identifier: NCT01394562
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Vifor (International) Inc.

Tracking Information
First Submitted Date  ICMJE July 12, 2011
First Posted Date  ICMJE July 14, 2011
Last Update Posted Date May 18, 2017
Study Start Date  ICMJE July 2011
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
Change in Peak VO2 (mL/kg/min) from baseline to Week 24 [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure
Official Title  ICMJE Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients With Iron Deficiency
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Iron Deficiency
  • Chronic Heart Failure
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * van Veldhuisen DJ, Ponikowski P, van der Meer P, Metra M, Böhm M, Doletsky A, Voors AA, Macdougall IC, Anker SD, Roubert B, Zakin L, Cohen-Solal A; EFFECT-HF Investigators. Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Chronic Heart Failure and Iron Deficiency. Circulation. 2017 Oct 10;136(15):1374-1383. doi: 10.1161/CIRCULATIONAHA.117.027497. Epub 2017 Jul 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2015)
174
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2011)
160
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01394562
Other Study ID Numbers  ICMJE FER-CARS-04
2011-000603-40 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vifor (International) Inc.
Study Sponsor  ICMJE Vifor (International) Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dirk van Veldhuisen, MD University Medical Center Groningen
PRS Account Vifor (International) Inc.
Verification Date December 2015

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