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

This study is currently recruiting participants.
Verified November 2012 by Vifor Inc.
Sponsor:
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01394562
First received: July 12, 2011
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Iron Deficiency
Chronic Heart Failure
 Drug: Ferinject (ferric carboxymaltose)
Other: Standard of Care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • Change in Peak VO2 (mL/kg/min) from baseline to Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: July 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394562

Contacts
Contact: Nicola Waddingham +44 1276 853600 nicola.waddingham@viforpharma.com

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

No publications provided

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01394562     History of Changes
Other Study ID Numbers: FER-CARS-04
Study First Received: July 12, 2011
Last Updated: November 13, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: 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 May 23, 2013