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EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure (EFFICACY-HF)

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ClinicalTrials.gov Identifier: NCT00821717
Recruitment Status : Terminated (Positive FAIR-HF study data are available, this study is identical as EFFICACY-HF. Due to low recruitment in EFFICACY-HF the decision was made to terminate it.)
First Posted : January 13, 2009
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Socar Research SA
Information provided by (Responsible Party):
Vifor (International) Inc.

Study Description
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Brief Summary:
This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Iron Deficiency Iron Deficiency Anemia Anaemia Drug: Ferinject ® (Ferric carboxymaltose) Drug: Normal saline (0.9%) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Controlled, Observer-blinded Phase III Clinical Trial to Compare the Effect of Intravenous Ferric Carboxymaltose to Placebo on Exercise Capacity and Cardiac Function in Patients With Chronic Heart Failure and Iron Deficiency
Study Start Date : December 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : January 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1: Drug: Ferinject ® (Ferric carboxymaltose)

Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit.

After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase).
Placebo Comparator: 2 Drug: Normal saline (0.9%)
During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.


Outcome Measures
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Primary Outcome Measures :
  1. The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks [ Time Frame: 24 weeks ]
  2. NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Cardiac function assessed by 2D Echo/Doppler cardiography [ Time Frame: 24 weeks ]
  2. Self-reported patient global assessment of treatment [ Time Frame: 24 weeks ]
  3. QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF)
  • Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III
  • Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations)
  • Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%

Exclusion Criteria:

  • History of acquired iron overload.
  • Known active infection, clinically significant bleeding, active malignancy.
  • Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST)
  • Anaemia due to reasons other than iron deficiency
  • Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
  • History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
  • Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
  • Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months.
  • Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
Contacts and Locations
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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): NCT00821717


Locations
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Denmark
Research Site
Copenhagen S, Denmark
Research Site
Esbjerg, Denmark
Research Site
Fredericia, Denmark
Research Site
Glostrup, Denmark
Research Site
Hellerup, Denmark
Research Site
Herning, Denmark
Research Site
Hilleroed, Denmark
Research Site
Svendborg, Denmark
France
Research Site
Boulogne, France
Research Site
Dijon, France
Research Site
Lyon, France
Research Site
Montpellier, France
Research Site
Nantes, France
Research Site
Pontoise, France
Research Site
Rennes, France
Research Site
Saintes, France
Research Site
Strasbourg, France
Germany
Research Site
Dueren, Germany
Research Site
Frankfurt, Germany
Research Site
Homburg/Saar, Germany
Research Site
Koeln, Germany
Research Site
Mainz, Germany
Research Site
Würzburg, Germany
Israel
Research Site
Afula, Israel
Research Site
Ashkelon, Israel
Research Site
Haifa, Israel
Research Site
Holon, Israel
Research Site
Jerusalem, Israel
Research Site
Kfar-Saba, Israel
Research Site
Rehovot, Israel
Research Site
Tel-Aviv, Israel
Research Site
Tel-Hashomer, Israel
Research Site
Zefat, Israel
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Den Bosch, Netherlands
Research Site
Eindhoven, Netherlands
Research Site
Heerenveen, Netherlands
Research Site
Leiden, Netherlands
Research Site
Nieuwegein, Netherlands
Research Site
Tilburg, Netherlands
Research Site
Utrecht, Netherlands
Sponsors and Collaborators
Vifor (International) Inc.
Socar Research SA
Investigators
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Study Chair: Michael Motro, MD, FACC Sheba Medical Center, Tel-Hashomer 52621, Israel
More Information
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Responsible Party: Vifor (International) Inc.
ClinicalTrials.gov Identifier: NCT00821717    
Other Study ID Numbers: FER-CARS-03
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Keywords provided by Vifor (International) Inc.:
Chronic Heart Failure
Iron deficiency
Iron deficiency anaemia
Anaemia
Heart disease
Additional relevant MeSH terms:
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Heart Failure
Anemia
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
 Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases