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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 Inc.

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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Chronic Heart Failure Drug: Ferinject (ferric carboxymaltose) Other: Standard of Care Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients With Iron Deficiency
Study Start Date : July 2011
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ferinject (ferric carboxymaltose) Drug: Ferinject (ferric carboxymaltose)
Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12
Standard of Care
Standard of care. IV iron is not permitted
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



Primary Outcome Measures :
  1. Change in Peak VO2 (mL/kg/min) from baseline to Week 24 [ Time Frame: Week 24 ]


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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 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

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): NCT01394562


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
Vifor Inc.
Investigators
Principal Investigator: Dirk van Veldhuisen, MD University Medical Center Groningen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01394562     History of Changes
Other Study ID Numbers: FER-CARS-04
2011-000603-40 ( EudraCT Number )
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: December 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