Cardiovascular DiseasesPhase 3iCHF-2NCT03991000
Iron in Patients With Cardiovascular Disease
A Phase 3 study testing Ferric carboxymaltose and Saline in people with Cardiovascular Diseases and Anemia, Iron-deficiency, run by Dr. med. Mahir Karakas at 3 sites in Germany.
Trial summary
It is now recognized that iron deficiency in cardiovascular disease contributes to impaired clinical outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Anemia, Iron-deficiency, Acute Myocardial Infarction
- What is being tested?
- Ferric carboxymaltose and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 3 sitesGermany
- Study dates
- 28 Feb 2019to 15 Dec 2021
- 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
- Cohort A (acute myocardial infarction): Acute Myocardial Infarction within 10 days (randomization/ first iron supplementation/ MRI must be performed within 10 days after AMI), without prior heart failure (defined as any known previous report of LVEF ≤ 45%) Cohort B (atrial fibrillation): Paroxysmal Atrial fibrillation or persistent AF Cohort C (heart failure): Left-ventricular ejection fraction ≤ 45 % (documented within the last 12 months prior to screening), all NYHA classes allowed
- Confirmed presence of iron deficiency (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with transferrin saturation < 20 %)
- Haemoglobin ≤ 15.5 g/dL
- Written informed consent
Who cannot join
- Evidence of iron overload or disturbances in the utilisation of iron
- History of severe asthma, eczema or other atopic allergy
- History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
- Use of renal replacement therapy
- Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 4 weeks prior to randomisation.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University of Berlin, Campus Benjamin-Franklin
Berlin, 12203
University Heart Center Hamburg
Hamburg, 20246
University of Ulm
Ulm, 89081
About this study
Official title: Investigator-initiated, Randomized, Double-blind, Controlled, Multi-center Trial of Intravenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency
It is now recognized that iron deficiency in cardiovascular disease contributes to impaired clinical outcome.
Read the detailed description
The clinical trial is designed as a prospective, multi-centre, double-blind, randomised, controlled, interventional trial to investigate whether a therapy with i.v. iron (iron carboxymaltose) compared to saline can improve functional status across a subset of cardiovascular disease -namely acute myocardial infarction, atrial fibrillation, and heart failure with reduced ejection fraction.
Iron administration will be carried out according to summary of product characteristics. Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg iron carboxymaltose (over 15 minutes), except when haemoglobin is > 16.0 g/dL or ferritin is > 600 µg/L.
- Conditions
- Cardiovascular Diseases, Anemia, Iron-deficiency, Acute Myocardial Infarction, Atrial Fibrillation, Systolic Heart Failure
- Being tested
- Ferric carboxymaltose, Saline
- Keywords
- Iron deficiency, Atrial fibrillation, Acute myocardial infarction, Systolic heart failure, Anemia
- Medical subject headings
- Cardiovascular Diseases, Anemia, Iron-Deficiency, Atrial Fibrillation, Heart Failure, Systolic, Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Intravenous iron
SalineDrug
Saline application according to dosing rules of iron.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous iron | Experimental | Intravenous iron administration in the form of ferric carboxymaltose will be carried out according to summary of product characteristics. Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg ferric carboxymaltose at months 4 and 8, except when haemoglobin is > 16.0 g/dL or ferritin is > 600 µg/L. To avoid unblinding in these patients a saline infusion will be administered. Receives: Drug: Ferric carboxymaltose |
| Placebo | Placebo comparator | Administration of i.v. NaCl according to the dosing rules for intravenous iron. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A: Left-ventricular ejection fraction
Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI
Measured: 16 weeks
Cohort B: Burden of atrial fibrillation
Delta between treatment groups in burden of atrial fibrillation from day 90 to 365 as assessed by a routinely implanted event recorder.
Measured: 12 months
Cohort C: Left-ventricular ejection fraction
Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start28 Feb 2019
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Why it stopped: Due to poor recruitment largely due to the covid pandemic, no safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. med. Mahir Karakas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Mahir Karakas, MD, MBA, Principal investigator, University Heart Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991000
- Sponsor's protocol ID
- iCHF-2
- Acronym
- iCHF-2
- Status last verified
- Dec 2023
- First submitted
- 17 Jun 2019
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-initiated, Randomized, Double-blind, Controlled, Multi-center Trial of Intravenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency
- ClinicalTrials.gov ID
- NCT03991000
- Acronym / sponsor ID
- iCHF-2 / iCHF-2
- Conditions
- Cardiovascular Diseases, Anemia, Iron-deficiency, Acute Myocardial Infarction, Atrial Fibrillation, Systolic Heart Failure
- Keywords
- Iron deficiency, Atrial fibrillation, Acute myocardial infarction, Systolic heart failure, Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor recruitment largely due to the covid pandemic, no safety concerns.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dr. med. Mahir KarakasUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 19 Jun 2019 (actual)
- 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.
It is now recognized that iron deficiency in cardiovascular disease contributes to impaired clinical outcome.
Detailed description
The clinical trial is designed as a prospective, multi-centre, double-blind, randomised, controlled, interventional trial to investigate whether a therapy with i.v. iron (iron carboxymaltose) compared to saline can improve functional status across a subset of cardiovascular disease -namely acute myocardial infarction, atrial fibrillation, and heart failure with reduced ejection fraction.
Iron administration will be carried out according to summary of product characteristics. Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg iron carboxymaltose (over 15 minutes), except when haemoglobin is > 16.0 g/dL or ferritin is > 600 µg/L.
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 |
|---|---|---|
| Intravenous iron | Experimental | Drug: Ferric carboxymaltoseIntravenous iron administration in the form of ferric carboxymaltose will be carried out according to summary of product characteristics. Bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg ferric carboxymaltose at months 4 and 8, except when haemoglobin is > 16.0 g/dL or ferritin is > 600 µg/L. To avoid unblinding in these patients a saline infusion will be administered. |
| Placebo | Placebo comparator | Drug: SalineAdministration of i.v. NaCl according to the dosing rules for intravenous iron. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cohort A (acute myocardial infarction): Acute Myocardial Infarction within 10 days (randomization/ first iron supplementation/ MRI must be performed within 10 days after AMI), without prior heart failure (defined as any known previous report of LVEF ≤ 45%) Cohort B (atrial fibrillation): Paroxysmal Atrial fibrillation or persistent AF Cohort C (heart failure): Left-ventricular ejection fraction ≤ 45 % (documented within the last 12 months prior to screening), all NYHA classes allowed
- Confirmed presence of iron deficiency (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with transferrin saturation < 20 %)
- Haemoglobin ≤ 15.5 g/dL
- Written informed consent
Key exclusion criteria (5 listed)
- Evidence of iron overload or disturbances in the utilisation of iron
- History of severe asthma, eczema or other atopic allergy
- History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
- Use of renal replacement therapy
- Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 4 weeks prior to randomisation.
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 carboxymaltoseIntravenous iron | Drug | Intravenous iron |
| SalineSaline application according to dosing rules of iron. | Drug | Placebo |
Primary outcome
Cohort A: Left-ventricular ejection fraction
Time frame: 16 weeks
Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI
Cohort B: Burden of atrial fibrillation
Time frame: 12 months
Delta between treatment groups in burden of atrial fibrillation from day 90 to 365 as assessed by a routinely implanted event recorder.
Cohort C: Left-ventricular ejection fraction
Time frame: 16 weeks
Change from baseline to week 16 in left-ventricular ejection fraction as determined by cardiac-MRI.
Results and safety
The study was stopped early (reason given: Due to poor recruitment largely due to the covid pandemic, no safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
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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, MBA principal investigator
University Heart Center Hamburg
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 and Saline in people with Cardiovascular Diseases and Anemia, Iron-deficiency, run by Dr. med. Mahir Karakas 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 4 inclusion and 5 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 27 Dec 2023. 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: Due to poor recruitment largely due to the covid pandemic, no safety concerns.). 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?
Cohort A: Left-ventricular ejection fraction (time frame: 16 weeks). The study lists 3 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 27 Dec 2023.