Back to resultsEFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure (EFFICACY-HF)
Primary Purpose
Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ferinject ® (Ferric carboxymaltose)
Normal saline (0.9%)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, Iron deficiency, Iron deficiency anaemia, Anaemia, Heart disease
Eligibility 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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1:
2
Arm Description
Outcomes
Primary Outcome Measures
The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks
NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment
Secondary Outcome Measures
Cardiac function assessed by 2D Echo/Doppler cardiography
Self-reported patient global assessment of treatment
QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi
Full Information
NCT ID
NCT00821717
First Posted
January 7, 2009
Last Updated
June 1, 2015
Sponsor
Vifor Pharma
Collaborators
Socar Research SA
1. Study Identification
Unique Protocol Identification Number
NCT00821717
Brief Title
EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure
Acronym
EFFICACY-HF
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 Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vifor Pharma
Collaborators
Socar Research SA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia, Anaemia
Keywords
Chronic Heart Failure, Iron deficiency, Iron deficiency anaemia, Anaemia, Heart disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1:
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ferinject ® (Ferric carboxymaltose)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Normal saline (0.9%)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks
Time Frame
24 weeks
Title
NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Cardiac function assessed by 2D Echo/Doppler cardiography
Time Frame
24 weeks
Title
Self-reported patient global assessment of treatment
Time Frame
24 weeks
Title
QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Motro, MD, FACC
Organizational Affiliation
Sheba Medical Center, Tel-Hashomer 52621, Israel
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Copenhagen S
Country
Denmark
Facility Name
Research Site
City
Esbjerg
Country
Denmark
Facility Name
Research Site
City
Fredericia
Country
Denmark
Facility Name
Research Site
City
Glostrup
Country
Denmark
Facility Name
Research Site
City
Hellerup
Country
Denmark
Facility Name
Research Site
City
Herning
Country
Denmark
Facility Name
Research Site
City
Hilleroed
Country
Denmark
Facility Name
Research Site
City
Svendborg
Country
Denmark
Facility Name
Research Site
City
Boulogne
Country
France
Facility Name
Research Site
City
Dijon
Country
France
Facility Name
Research Site
City
Lyon
Country
France
Facility Name
Research Site
City
Montpellier
Country
France
Facility Name
Research Site
City
Nantes
Country
France
Facility Name
Research Site
City
Pontoise
Country
France
Facility Name
Research Site
City
Rennes
Country
France
Facility Name
Research Site
City
Saintes
Country
France
Facility Name
Research Site
City
Strasbourg
Country
France
Facility Name
Research Site
City
Dueren
Country
Germany
Facility Name
Research Site
City
Frankfurt
Country
Germany
Facility Name
Research Site
City
Homburg/Saar
Country
Germany
Facility Name
Research Site
City
Koeln
Country
Germany
Facility Name
Research Site
City
Mainz
Country
Germany
Facility Name
Research Site
City
Würzburg
Country
Germany
Facility Name
Research Site
City
Afula
Country
Israel
Facility Name
Research Site
City
Ashkelon
Country
Israel
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Holon
Country
Israel
Facility Name
Research Site
City
Jerusalem
Country
Israel
Facility Name
Research Site
City
Kfar-Saba
Country
Israel
Facility Name
Research Site
City
Rehovot
Country
Israel
Facility Name
Research Site
City
Tel-Aviv
Country
Israel
Facility Name
Research Site
City
Tel-Hashomer
Country
Israel
Facility Name
Research Site
City
Zefat
Country
Israel
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Den Bosch
Country
Netherlands
Facility Name
Research Site
City
Eindhoven
Country
Netherlands
Facility Name
Research Site
City
Heerenveen
Country
Netherlands
Facility Name
Research Site
City
Leiden
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
Country
Netherlands
Facility Name
Research Site
City
Tilburg
Country
Netherlands
Facility Name
Research Site
City
Utrecht
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure
We'll reach out to this number within 24 hrs