Heart FailurePhase 4IRON-CRTNCT03380520
Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy
A Phase 4 study testing Ferric Carboxymaltose in people with Heart Failure, run by Hasselt University at 1 site in Belgium.
Trial summary
To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Ferric Carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2017to 4 Aug 2021
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin < 100 μg/l, irrespective of TSAT or ferritine between 100 - 300 μg/l with TSAT < 20%) and presence of incomplete reverse remodeling (LVEF < 40%).
- Age ≥18 years
- Obtained informed consent
- Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics)
Who cannot join
- Hemochromatosis, iron overload, defined as TSAT > 45%
- Hemoglobin > 15 g/dl at inclusion
- Known hypersensitivity to injectafer®.
- Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy.
- Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.
- Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
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- 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 ischemic 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.
- Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
- Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy).
- Pregnancy or lactation.
- Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
- Planned cardiac hospitalization during study follow-up
Trial locations and contacts
1 site in 1 country.
About this study
To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo
- Conditions
- Heart Failure
- Being tested
- Ferric Carboxymaltose, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric CarboxymaltoseDrug
Also called injectafer
Ferric carboxymaltose will be administered according to product specification dosing
PlaceboDrug
IV nacl 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose | Experimental | Ferric carboxymaltose according to SmPC Receives: Drug: Ferric Carboxymaltose |
| Placebo | Placebo comparator | Normal saline (0.9%) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular ejection fraction from baseline
delta_LVEF measured by 3D-echocardiography
Measured: 3 months
Secondary outcomes (5)
Change in left ventricular end systolic volume from baseline
delta_LVESV measured by 3D-echocardiography
Measured: 3 months
Change in left ventricular end diastolic volume from baseline
delta_LVEDV measured by 3D-echocardiography
Measured: 3 months
Force frequency relationship
measured by 2D-echocardiography
Measured: 3 months
Heart failure hospitalization and all-cause mortality
measured by telephone contact
Measured: Up to six months
Incidence of Treatment-associated Serious and non-serious adverse events.
Serious and non-serious adverse events (AE) will be registered, which include:start date AE, duration AE, end-date AE, treatment group, continuation of AE after dose interruption, causality with study medication, presence of risk factors for AE and response to AE (sequela or recovery).
Measured: During intravenous study drug administration and 1-hour in hospital follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Oct 2017
- Primary completion31 Dec 2020
- Study completion4 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Wilfried Mullens, MD PhD, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380520
- Sponsor's protocol ID
- IRON-CRT
- Acronym
- IRON-CRT
- Status last verified
- Aug 2021
- First submitted
- 2 Nov 2017
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes, full patient level data
Publications
Martens P, Dupont M, Dauw J, Nijst P, Herbots L, Dendale P, Vandervoort P, Bruckers L, Tang WHW, Mullens W. The effect of intravenous ferric carboxymaltose on cardiac reverse remodelling following cardiac resynchronization therapy-the IRON-CRT trial. Eur Heart J. 2021 Dec 21;42(48):4905-4914. doi: 10.1093/eurheartj/ehab411.
PubMed 34185066
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT03380520
- Acronym / sponsor ID
- IRON-CRT / IRON-CRT
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 21 Dec 2017 (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.
To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo
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 |
|---|---|---|
| Ferric carboxymaltose | Experimental | Drug: Ferric CarboxymaltoseFerric carboxymaltose according to SmPC |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline (0.9%) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin < 100 μg/l, irrespective of TSAT or ferritine between 100 - 300 μg/l with TSAT < 20%) and presence of incomplete reverse remodeling (LVEF < 40%).
- Age ≥18 years
- Obtained informed consent
- Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics)
Key exclusion criteria (15 listed)
- Hemochromatosis, iron overload, defined as TSAT > 45%
- Hemoglobin > 15 g/dl at inclusion
- Known hypersensitivity to injectafer®.
- Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy.
- Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.
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: injectaferFerric carboxymaltose will be administered according to product specification dosing | Drug | Ferric carboxymaltose |
| PlaceboIV nacl 0.9% | Drug | Placebo |
Primary outcome
Change in left ventricular ejection fraction from baseline
Time frame: 3 months
delta_LVEF measured by 3D-echocardiography
5 secondary outcomes
Change in left ventricular end systolic volume from baseline
Time frame: 3 months
Change in left ventricular end diastolic volume from baseline
Time frame: 3 months
Force frequency relationship
Time frame: 3 months
Heart failure hospitalization and all-cause mortality
Time frame: Up to six months
Incidence of Treatment-associated Serious and non-serious adverse events.
Time frame: During intravenous study drug administration and 1-hour in hospital follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Results publication: PubMed 34185066Martens P, Dupont M, Dauw J, Nijst P, Herbots L, Dendale P, Vandervoort P, Bruckers L, Tang WHW, Mullens W. The effect of intravenous ferric carboxymaltose on cardiac reverse remodelling following cardiac resynchronization therapy-the IRON-CRT trial. Eur Heart J. 2021 Dec 21;42(48):4905-4914. doi: 10.1093/eurheartj/ehab411.
- Individual participant dataSharing planned: Undecided. Yes, full patient level data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Carboxymaltose in people with Heart Failure, run by Hasselt University at 1 site in Belgium.
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 15 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: finished, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in left ventricular ejection fraction from baseline (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03380520, which also lists 1 linked publication.
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 11 Aug 2021.