Chronic Heart FailurePhase 3EFFICACY-HFNCT00821717
EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure
A Phase 3 study testing Ferinject ® (Ferric carboxymaltose) and Normal saline (0.9%) in people with Chronic Heart Failure and Iron Deficiency, run by Vifor Pharma at 41 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia
- What is being tested?
- Ferinject ® (Ferric carboxymaltose) and Normal saline (0.9%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 41 sitesin 5 countries
- Study dates
- Dec 2008to Jan 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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.
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- 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.
Trial locations and contacts
41 sites in 5 countries.
41 sites in 5 countries
Israel10 sites
Research Site
Afula
Research Site
Ashkelon
Research Site
Haifa
Research Site
Holon
Research Site
Jerusalem
Research Site
Kfar Saba
Research Site
Rehovot
Research Site
Safed
Research Site
Tel Aviv
Research Site
Tel HaShomer
France9 sites
Research Site
Boulogne
Research Site
Dijon
Research Site
Lyon
Research Site
Montpellier
Research Site
Nantes
Research Site
Pontoise
Research Site
Rennes
Research Site
Saintes
Research Site
Strasbourg
Denmark8 sites
Research Site
Copenhagen S
Research Site
Esbjerg
Research Site
Fredericia
Research Site
Glostrup Municipality
Research Site
Hellerup
Research Site
Herning
Research Site
Hilleroed
Research Site
Svendborg
Netherlands8 sites
Research Site
's-Hertogenbosch
Research Site
Amsterdam
Research Site
Eindhoven
Research Site
Heerenveen
Research Site
Leiden
Research Site
Nieuwegein
Research Site
Tilburg
Research Site
Utrecht
Germany6 sites
Research Site
Cologne
Research Site
Düren
Research Site
Frankfurt
Research Site
Homburg/Saar
Research Site
Mainz
Research Site
Würzburg
About this study
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
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.
- Being tested
- Ferinject ® (Ferric carboxymaltose), Normal saline (0.9%)
- Keywords
- Chronic Heart Failure, Iron deficiency, Iron deficiency anaemia, Anaemia, Heart disease
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency, Anemia, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferinject ® (Ferric carboxymaltose)Drug
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).
Normal saline (0.9%)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1: | Experimental | Not described Receives: Drug: Ferinject ® (Ferric carboxymaltose) |
| 2 | Placebo comparator | Not described Receives: Drug: Normal saline (0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks
Measured: 24 weeks
NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment
Measured: 24 weeks
Secondary outcomes (3)
Cardiac function assessed by 2D Echo/Doppler cardiography
Measured: 24 weeks
Self-reported patient global assessment of treatment
Measured: 24 weeks
QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionJan 2011
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Socar Research SA
- Responsible party
- Sponsor
- Investigators
- Michael Motro, MD, FACC, Study chair, Sheba Medical Center, Tel-Hashomer 52621, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821717
- Sponsor's protocol ID
- FER-CARS-03
- Acronym
- EFFICACY-HF
- Status last verified
- Jun 2015
- First submitted
- 7 Jan 2009
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00821717
- Acronym / sponsor ID
- EFFICACY-HF / FER-CARS-03
- Keywords
- Chronic Heart Failure, Iron deficiency, Iron deficiency anaemia, Anaemia, Heart disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Socar Research SA
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: | Experimental | Drug: Ferinject ® (Ferric carboxymaltose) |
| 2 | Placebo comparator | Drug: Normal saline (0.9%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | 1: |
| 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. | Drug | 2 |
Primary outcome
The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks
Time frame: 24 weeks
NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment
Time frame: 24 weeks
3 secondary outcomes
Cardiac function assessed by 2D Echo/Doppler cardiography
Time frame: 24 weeks
Self-reported patient global assessment of treatment
Time frame: 24 weeks
QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Motro, MD, FACC study chair
Sheba Medical Center, Tel-Hashomer 52621, Israel
41 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferinject ® (Ferric carboxymaltose) and Normal saline (0.9%) in people with Chronic Heart Failure and Iron Deficiency, run by Vifor Pharma at 41 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Israel, France, Denmark, Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.