Cardiac TransplantPhase 2/3DECIFERNCT02319278
DEtection of Cellular Inflammation With FERumoxytol in the HEART
A Phase 2/3 study testing Ferumoxytol in people with Cardiac Transplant and Cardiac Sarcoid, run by University of Edinburgh at 3 sites in United Kingdom.
Trial summary
To non-invasively image myocardial accumulation of ultrasmall superparamagnetic particles of iron oxide (USPIOs) by an increase in R2* values (compared to controls) within the myocardium of patients with: i. cardiac transplantation ii. acute myocarditis iii. suspected cardiac sarcoidosis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Transplant, Cardiac Sarcoid, Myocarditis
- What is being tested?
- Ferumoxytol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Dec 2014to Nov 2016
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- One of the four conditions below:
- Patients having undergone cardiac transplant
- Patients diagnosed clinically with myocarditis of any aetiology (eg viral, septic, post chemotherapeutic etc)
- Patients clinically diagnosed with cardiac sarcoidosis
- Healthy volunteers
- Age > 18 years.
Who cannot join
- Contraindication to magnetic resonance imaging scanning identified from magnetic resonance imaging safety questionnaire
- Patients refusing or unable to give informed consent
- Renal failure (estimated glomerular filtration rate <30 mL/min)
- Polycythemia
- Contraindication to ferumoxytol (previous allergic drug reaction, any immune or inflammatory conditions (eg, systemic lupus erythematosus, rheumatoid arthritis, history of severe asthma, eczema or other atopic allergy)), evidence of known iron overload, hemochromatosis, known hypersensitivity to ferumoxytol or its components or anaemia not caused by iron deficiency.
- Known allergy to dextran- or iron-containing compounds.
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- Diagnosis of myocardial infarction within 1 month.
- Pregnancy or Breast-feeding.
- Women of child bearing age not ensuring reliable methods of contraception. Female participants of child bearing age will be asked if they are ensuring reliable methods of contraception prior to each administration of USPIO and MRI scan. If use of reliable contraception cannot be confirmed, the participant will be withdrawn.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Royal Infirmary of Edinburgh
Edinburgh
Golden Jubilee National Hospital
Glasgow
Royal Brompton Hospital
London
About this study
To non-invasively image myocardial accumulation of ultrasmall superparamagnetic particles of iron oxide (USPIOs) by an increase in R2* values (compared to controls) within the myocardium of patients with:
- cardiac transplantation ii. acute myocarditis iii. suspected cardiac sarcoidosis
Read the detailed description
Ferumoxytol is a 'smart' magnetic resonance contrast agent consisting of ultrasmall superparamagnetic particles of iron oxide (USPIOs) that are taken up by macrophages. Concentration of USPIOs within macrophages changes the tissue relaxation properties and this can be detected by magnetic resonance imaging using R2* maps. In a recent early proof-of-concept study, we demonstrated that macrophages could be detected with USPIOs in the penumbra and infarct zone of the myocardium in patients with a recent myocardial infarction. The investigators therefore wish to establish whether USPIOs can be used to identify cellular inflammation within the myocardium in three distinct clinical conditions that currently lack a non-invasive diagnostic imaging test: cardiac allograft rejection, viral myocarditis and cardiac sarcoidosis. If successful, this would not only provide a useful diagnostic test but would also be a method of monitoring disease progression or response to therapy.
- Conditions
- Cardiac Transplant, Cardiac Sarcoid, Myocarditis, Healthy Volunteers
- Being tested
- Ferumoxytol
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
Infusion following between paired MRI scans
| Study group | Role | What they receive |
|---|---|---|
| Myocarditis | Active comparator | Not described Receives: Drug: Ferumoxytol |
| Cardiac sarcoid | Active comparator | Not described Receives: Drug: Ferumoxytol |
| Cardiac Transplant | Active comparator | Not described Receives: Drug: Ferumoxytol |
| Healthy Volunteers | Placebo comparator | Not described Receives: Drug: Ferumoxytol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Myocardial Cellular Inflammation.
Assessment of Myocardial Cellular Inflammation through the increase in R2* value on post USPIO imaging versus baseline imaging.
Measured: 1 year
Secondary outcomes (3)
Correlation of R2* values with circulating inflammatory markers
Comparison of circulating inflammatory markers in peripheral blood with myocardial inflammation (seen on cardiac R2* maps) .
Measured: 1 year
Does clinical condition correlate with inflammation seen on R2* maps. (assessed by reduction in R2* values)
Does treatment or recovery from these inflammatory myocardial conditions reduce or halt uptake of USPIOs as assessed by reduction in R2* values.
Measured: 1 year
Do higher R2* correlate with poorer outcome? (assessed by deterioration in ejection fraction or increase in late gadolinium enhancement)
Do patients with higher R2* values have worse outcomes assessed by deterioration in ejection fraction or increase in late gadolinium enhancement.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac TransplantStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Infirmary of Edinburgh, Golden Jubilee National Hospital, Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Colin Stirrat, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319278
- Sponsor's protocol ID
- 2013-002336-24
- Acronym
- DECIFER
- Status last verified
- May 2017
- First submitted
- 3 Dec 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Stirrat CG, Alam S, MacGillivray TJ, Gray C, Dweck MR, Jones V, Wallace W, Payne JR, Prasad SK, Gardner RS, Petrie MC, Mirsadraee S, Henriksen P, Newby DE, Semple S. Ferumoxytol-enhanced MRI in patients with prior cardiac transplantation. Open Heart. 2019 Oct 3;6(2):e001115. doi: 10.1136/openhrt-2019-001115. eCollection 2019.
PubMed 31673393Stirrat CG, Alam SR, MacGillivray TJ, Gray CD, Dweck MR, Dibb K, Spath N, Payne JR, Prasad SK, Gardner RS, Mirsadraee S, Henriksen PA, Semple SI, Newby DE. Ferumoxytol-enhanced magnetic resonance imaging in acute myocarditis. Heart. 2018 Feb;104(4):300-305. doi: 10.1136/heartjnl-2017-311688. Epub 2017 Oct 6.
PubMed 28986407Stirrat CG, Alam SR, MacGillivray TJ, Gray CD, Dweck MR, Raftis J, Jenkins WS, Wallace WA, Pessotto R, Lim KH, Mirsadraee S, Henriksen PA, Semple SI, Newby DE. Ferumoxytol-enhanced magnetic resonance imaging assessing inflammation after myocardial infarction. Heart. 2017 Oct;103(19):1528-1535. doi: 10.1136/heartjnl-2016-311018. Epub 2017 Jun 22.
PubMed 28642288Stirrat CG, Alam SR, MacGillivray TJ, Gray CD, Forsythe R, Dweck MR, Payne JR, Prasad SK, Petrie MC, Gardner RS, Mirsadraee S, Henriksen PA, Newby DE, Semple SI. Ferumoxytol-enhanced magnetic resonance imaging methodology and normal values at 1.5 and 3T. J Cardiovasc Magn Reson. 2016 Jul 27;18(1):46. doi: 10.1186/s12968-016-0261-2.
PubMed 27465647
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEtection of Cellular Inflammation With FERumoxytol in the HEART
- ClinicalTrials.gov ID
- NCT02319278
- Acronym / sponsor ID
- DECIFER / 2013-002336-24
- Conditions
- Cardiac Transplant, Cardiac Sarcoid, Myocarditis, Healthy Volunteers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Royal Infirmary of Edinburgh, Golden Jubilee National Hospital, Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Dec 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Dec 2014 (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.
To non-invasively image myocardial accumulation of ultrasmall superparamagnetic particles of iron oxide (USPIOs) by an increase in R2* values (compared to controls) within the myocardium of patients with:
- cardiac transplantation ii. acute myocarditis iii. suspected cardiac sarcoidosis
Detailed description
Ferumoxytol is a 'smart' magnetic resonance contrast agent consisting of ultrasmall superparamagnetic particles of iron oxide (USPIOs) that are taken up by macrophages. Concentration of USPIOs within macrophages changes the tissue relaxation properties and this can be detected by magnetic resonance imaging using R2* maps. In a recent early proof-of-concept study, we demonstrated that macrophages could be detected with USPIOs in the penumbra and infarct zone of the myocardium in patients with a recent myocardial infarction. The investigators therefore wish to establish whether USPIOs can be used to identify cellular inflammation within the myocardium in three distinct clinical conditions that currently lack a non-invasive diagnostic imaging test: cardiac allograft rejection, viral myocarditis and cardiac sarcoidosis. If successful, this would not only provide a useful diagnostic test but would also be a method of monitoring disease progression or response to therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Myocarditis | Active comparator | Drug: Ferumoxytol |
| Cardiac sarcoid | Active comparator | Drug: Ferumoxytol |
| Cardiac Transplant | Active comparator | Drug: Ferumoxytol |
| Healthy Volunteers | Placebo comparator | Drug: Ferumoxytol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- One of the four conditions below:
- Age > 18 years.
Key exclusion criteria (9 listed)
- Contraindication to magnetic resonance imaging scanning identified from magnetic resonance imaging safety questionnaire
- Patients refusing or unable to give informed consent
- Renal failure (estimated glomerular filtration rate <30 mL/min)
- Polycythemia
- Contraindication to ferumoxytol (previous allergic drug reaction, any immune or inflammatory conditions (eg, systemic lupus erythematosus, rheumatoid arthritis, history of severe asthma, eczema or other atopic allergy)), evidence of known iron overload, hemochromatosis, known hypersensitivity to ferumoxytol or its components or anaemia 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 |
|---|---|---|
| FerumoxytolInfusion following between paired MRI scans | Drug | Cardiac Transplant, Cardiac sarcoid, Healthy Volunteers, Myocarditis |
Primary outcome
Assessment of Myocardial Cellular Inflammation.
Time frame: 1 year
Assessment of Myocardial Cellular Inflammation through the increase in R2* value on post USPIO imaging versus baseline imaging.
3 secondary outcomes
Correlation of R2* values with circulating inflammatory markers
Time frame: 1 year
Does clinical condition correlate with inflammation seen on R2* maps. (assessed by reduction in R2* values)
Time frame: 1 year
Do higher R2* correlate with poorer outcome? (assessed by deterioration in ejection fraction or increase in late gadolinium enhancement)
Time frame: 1 year
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 3 May 2017.
- Derived from this study: PubMed 31673393Stirrat CG, Alam S, MacGillivray TJ, Gray C, Dweck MR, Jones V, Wallace W, Payne JR, Prasad SK, Gardner RS, Petrie MC, Mirsadraee S, Henriksen P, Newby DE, Semple S. Ferumoxytol-enhanced MRI in patients with prior cardiac transplantation. Open Heart. 2019 Oct 3;6(2):e001115. doi: 10.1136/openhrt-2019-001115. eCollection 2019.
- Derived from this study: PubMed 28986407Stirrat CG, Alam SR, MacGillivray TJ, Gray CD, Dweck MR, Dibb K, Spath N, Payne JR, Prasad SK, Gardner RS, Mirsadraee S, Henriksen PA, Semple SI, Newby DE. Ferumoxytol-enhanced magnetic resonance imaging in acute myocarditis. Heart. 2018 Feb;104(4):300-305. doi: 10.1136/heartjnl-2017-311688. Epub 2017 Oct 6.
- Derived from this study: PubMed 28642288Stirrat CG, Alam SR, MacGillivray TJ, Gray CD, Dweck MR, Raftis J, Jenkins WS, Wallace WA, Pessotto R, Lim KH, Mirsadraee S, Henriksen PA, Semple SI, Newby DE. Ferumoxytol-enhanced magnetic resonance imaging assessing inflammation after myocardial infarction. Heart. 2017 Oct;103(19):1528-1535. doi: 10.1136/heartjnl-2016-311018. Epub 2017 Jun 22.
- Derived from this study: PubMed 27465647Stirrat CG, Alam SR, MacGillivray TJ, Gray CD, Forsythe R, Dweck MR, Payne JR, Prasad SK, Petrie MC, Gardner RS, Mirsadraee S, Henriksen PA, Newby DE, Semple SI. Ferumoxytol-enhanced magnetic resonance imaging methodology and normal values at 1.5 and 3T. J Cardiovasc Magn Reson. 2016 Jul 27;18(1):46. doi: 10.1186/s12968-016-0261-2.
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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.
Colin Stirrat, MBChB principal investigator
University of Edinburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ferumoxytol in people with Cardiac Transplant and Cardiac Sarcoid, run by University of Edinburgh at 3 sites in United Kingdom.
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 6 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: finished, as of the sponsor's last update on 3 May 2017. 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 United Kingdom. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Assessment of Myocardial Cellular Inflammation. (time frame: 1 year). 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 NCT02319278, which also lists 4 linked publications.
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 May 2017.