Heart FailurePhase 3iCHFNCT01837082
Iron in Congestive Heart Failure
A Phase 3 study testing ferric carboxymaltose in people with Heart Failure and Iron Deficiency, run by University of Ulm at 3 sites in Germany.
Trial summary
The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve left-ventricular ejection fraction in patients with heart failure and iron deficiency as determined by cardiac magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Iron Deficiency, Anemia
- What is being tested?
- ferric carboxymaltose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 3 sitesGermany
- Study dates
- Apr 2013to Dec 2015
- 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
- Congestive heart failure
- At least 18 years of age
- Iron deficiency
- Dyspnea class II or III according to New York Heart Association
- Left-ventricular ejection fraction ≤ 45%
Who cannot join
- Known sensitivity to any of the products to be administered during dosing
- Immediate need of transfusion
- Patients presenting with an active infection
- Thalassaemia
- Other forms of microcytic anemia not caused by iron deficiency
- History of acquired iron overload
- Need for revascularization, ST-segment elevation myocardial infarction or Non-ST-segment elevation myocardial infarction during the past 3 months (at time of randomization)
- Women who are pregnant or of childbearing age and not using medically acceptable effective contraception
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University of Aachen
Aachen, 52074
University Heart Center Hamburg
Hamburg, 20251
University of Ulm
Ulm, 89081
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients With Congestive Heart Failure
The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve left-ventricular ejection fraction in patients with heart failure and iron deficiency as determined by cardiac magnetic resonance imaging.
- Conditions
- Heart Failure, Iron Deficiency, Anemia
- Being tested
- ferric carboxymaltose, Placebo
- Keywords
- Heart Failure, Iron Deficiency, Anemia, Ferric Carboxymaltose
- Medical subject headings
- Heart Failure, Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferric carboxymaltoseDrug
Also called Ferinject
PlaceboDrug
Also called Sodium chloride 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Iron | Active comparator | ferric carboxymaltose Receives: Drug: ferric carboxymaltose |
| Placebo | Placebo comparator | Sodium chloride 0.9% Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is the change from baseline to week 12 in left-ventricular ejection fraction as determined by cardiac magnetic resonance imaging.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- RWTH Aachen University, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Dr. Mahir Karakas, University of Ulm
- Investigators
- Mahir Karakas, MD, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837082
- Sponsor's protocol ID
- iCHF_D.3874
- Other IDs
- 2012-001134-33
- Acronym
- iCHF
- Status last verified
- May 2016
- First submitted
- 17 Apr 2013
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT01837082
- Acronym / sponsor ID
- iCHF / iCHF_D.3874
- Conditions
- Heart Failure, Iron Deficiency, Anemia
- Keywords
- Heart Failure, Iron Deficiency, Anemia, Ferric Carboxymaltose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- RWTH Aachen University, Universitätsklinikum Hamburg-Eppendorf
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Apr 2013 (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.
The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve left-ventricular ejection fraction in patients with heart failure and iron deficiency as determined by cardiac magnetic resonance imaging.
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 |
|---|---|---|
| Iron | Active comparator | Drug: ferric carboxymaltoseferric carboxymaltose |
| Placebo | Placebo comparator | Drug: PlaceboSodium chloride 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Congestive heart failure
- At least 18 years of age
- Iron deficiency
- Dyspnea class II or III according to New York Heart Association
- Left-ventricular ejection fraction ≤ 45%
Key exclusion criteria (8 listed)
- Known sensitivity to any of the products to be administered during dosing
- Immediate need of transfusion
- Patients presenting with an active infection
- Thalassaemia
- Other forms of microcytic anemia not caused by iron deficiency
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 |
|---|---|---|
| ferric carboxymaltoseAlso: Ferinject | Drug | Iron |
| PlaceboAlso: Sodium chloride 0.9% | Drug | Placebo |
Primary outcome
The primary endpoint of the study is the change from baseline to week 12 in left-ventricular ejection fraction as determined by cardiac magnetic resonance imaging.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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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.
Mahir Karakas, MD principal investigator
University of Ulm
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ferric carboxymaltose in people with Heart Failure and Iron Deficiency, run by University of Ulm at 3 sites in Germany.
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 5 inclusion and 8 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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: Insufficient recruitment). 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 primary endpoint of the study is the change from baseline to week 12 in left-ventricular ejection fraction as determined by cardiac magnetic resonance imaging. (time frame: 12 weeks). 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 13 May 2016.