Study 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.
EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure
EFFICACY-HF
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
1 other identifier
interventional
35
5 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2008
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 7, 2009
CompletedFirst Posted
Study publicly available on registry
January 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJune 3, 2015
June 1, 2015
10 months
January 7, 2009
June 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks
24 weeks
NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment
24 weeks
Secondary Outcomes (3)
Cardiac function assessed by 2D Echo/Doppler cardiography
24 weeks
Self-reported patient global assessment of treatment
24 weeks
QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi
24 weeks
Study Arms (2)
1:
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vifor Pharmalead
- Socar Research SAcollaborator
Study Sites (41)
Research Site
Copenhagen S, Denmark
Research Site
Esbjerg, Denmark
Research Site
Fredericia, Denmark
Research Site
Glostrup Municipality, Denmark
Research Site
Hellerup, Denmark
Research Site
Herning, Denmark
Research Site
Hilleroed, Denmark
Research Site
Svendborg, Denmark
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
Research Site
Cologne, Germany
Research Site
Düren, Germany
Research Site
Frankfurt, Germany
Research Site
Homburg/Saar, Germany
Research Site
Mainz, Germany
Research Site
Würzburg, Germany
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
Safed, Israel
Research Site
Tel Aviv, Israel
Research Site
Tel Litwinsky, Israel
Research Site
's-Hertogenbosch, Netherlands
Research Site
Amsterdam, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Motro, MD, FACC
Sheba Medical Center, Tel-Hashomer 52621, Israel
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2009
First Posted
January 13, 2009
Study Start
December 1, 2008
Primary Completion
October 1, 2009
Study Completion
January 1, 2011
Last Updated
June 3, 2015
Record last verified: 2015-06