Aortic StenosisFCDMINCT05756608
Fibrosis in Chronic and Delayed Myocardial Infarction
An observational study of Aortic Stenosis and Chemotherapy Induced Systolic Dysfunction, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
In this study the investigators aim to examine the role that fibrosis plays in heart conditions such as aortic stenosis , chemotherapy-induced cardiotoxicity and carcinoid syndrome . Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis, Chemotherapy Induced Systolic Dysfunction, Carcinoid Syndrome
- What is being tested?
- 68Ga-FAPI and 18F-AlF-FAPI PET-MR
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2022to 23 Jul 2026
- Phase
- Observational
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort 1: 70 patients with aortic stenosis with 10 matched healthy volunteers Cohort 2: 60 patients with Chemotherapy-induced cardiotoxicity and 10 healthy volunteers Cohort 3: 30 patients with carcinoid syndrome
Who may be able to join
- Cohort 1(Aortic stenosis):
- Male or female above the age of 50 years old
- Provision of informed consent prior to any study specific procedures
- 25 patients with symptomatic severe aortic stenosis (peak velocity >4.0 m/s)
- 25 patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s)
- 10 patients with mild aortic stenosis (peak velocity 2.6-2.9 m/s)
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- 10 patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow)
- 10 healthy volunteers (no other significant co-morbidities, as assessed by the study PI)
- Cohort 2 (Chemotherapy-induced cardiotoxicity):
- Male or female over the age of 35 years with evidence of cardiotoxicity on cardiac MRI (performed as part of the Cardiac care study), at least 1 year after anthracycline treatment.
- 10 patients over the age of 35 years (male or females) without evidence of fibrosis on their 1-year scan after anthracycline treatment.
- 10 healthy volunteers (>35 years of age) with no significant co-morbidities, as assessed by the study PI.
- Provision of informed consent prior to any study specific procedures
- Cohort 3 (Carcinoid syndrome):
- 30 patients with carcinoid syndrome (with or without cardiac involvement), over the age of 35 years, diagnosed as per consensus guidelines
- Provision of informed consent prior to any study specific procedures
Who cannot join
- Inability or unwilling to give informed consent.
- History of claustrophobia or feeling of inability to tolerate supine position for the MRI scans.
- Impaired renal function with eGFR of <30 mL/min/1.73m2.
- Women who are pregnant or breastfeeding.
- Contrast allergy
- Contraindication to cardiac MRI (e.g. metallic implant or severe claustrophobia)
- Recent myocardial infarction, other known causes of cardiomyopathy/cardiac fibrosis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh
Edinburgh, Scotland, NE7 7EY
About this study
In this study the investigators aim to examine the role that fibrosis plays in heart conditions such as aortic stenosis , chemotherapy-induced cardiotoxicity and carcinoid syndrome . Fibrosis is a common final result following any injury to the heart muscle and the investigators aim to identify this process early and in its active state. This will be examined by using a radiotracer 68Ga-FAPI or 18F-AlF-FAPI and PET-MRI or PET-CT.
Read the detailed description
The investigators aim to investigate the role of fibrosis activity using 68Ga-FAPI and 18F-AlF-FAPI PET in chronic and delayed valvular, myocardial and endocardial injury states, in particular aortic stenosis, chemotherapy induced cardiotoxicity and carcinoid heart disease. The investigators also aim to analyse serum markers of myocardial injury and fibrosis at different time-points in these patient cohorts.
Research Hypothesis
- In patients with aortic stenosis, myocardial fibrosis activity will correlate with markers of left ventricular decompensation and aortic valve fibrosis activity, will predict progression in fibrosis burden and will decline following aortic valve replacement.
- Increased myocardial fibrosis activity will be observed in the early stages of anthracycline- induced cardiotoxicity and will predict later deterioration in cardiac function.
- In patients with carcinoid syndrome, increased endocardial fibrosis activity will be observed in patients with subclinical and clinically significant valve involvement.
- Being tested
- 68Ga-FAPI and 18F-AlF-FAPI PET-MR
- Medical subject headings
- Aortic Valve Stenosis, Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI and 18F-AlF-FAPI PET-MRDiagnostic test
Hybrid Cardiac PET-MR with 68Ga-FAPI and 18F-AlF-FAPI radiotracer
| Study group | Role | What they receive |
|---|---|---|
| Aortic stenosis | The investigators will recruit 70 patients with aortic stenosis (25 patients with asymptomatic moderate aortic stenosis and 25 patients with symptomatic severe aortic stenosis, 10 patients with mild aortic stenosis and 10 patients with aortic sclerosis) and 10 healthy volunteers, who will undergo baseline 68Ga-FAPI or 18F-AlF-FAPI PET/MR imaging to establish fibrosis activity in healthy myocardium and in context of chronic myocardial injury. All patients will have a follow up FAPI PET/ MR scan 1 year after their baseline scan to assess whether myocardial fibrosis activity reverses following aortic valve replacement and restoration of normal afterload in patients with severe aortic stenosis and if baseline myocardial fibrosis activity can predict progression in the fibrosis burden and clinical progression in patients with mild or moderate aortic stenosis or aortic sclerosis. Healthy volunteers will not undergo any repeat imaging. Receives: Diagnostic Test: 68Ga-FAPI and 18F-AlF-FAPI PET-MR | |
| Chemotherapy-induced cardiotoxicity | The investigators will recruit 60 patients who have undergone anthracycline treatment >1 year from enrollment and 10 healthy volunteers as part of this cohort. This will include 50 patients who have either clear evidence of cardiotoxicity (Ejection fraction <50% and a 10%point fall in ejection fraction) or a subclinical cardiac injury (elevated troponin, elevated T2, impaired global longitudinal strain) and 10 patients with no evidence of cardiotoxicity on their cardiac MRI scan (performed as part of the ongoing Cardiac CARE study). These patients will undergo baseline FAPI PET/MR imaging to establish the extent and pattern of myocardial fibrosis activity in context of delayed myocardial injury (chemotherapy-induced cardiotoxicity). All patients will have a follow up cardiac MRI scan 1-2 years after their baseline scan to assess whether baseline fibrosis activity is associated with a deterioration in cardiac function. Healthy volunteers will not undergo any repeat imaging. Receives: Diagnostic Test: 68Ga-FAPI and 18F-AlF-FAPI PET-MR | |
| Carcinoid syndrome | In collaboration with the South East Scotland NET Service, the investigators will recruit 30 patients with carcinoid syndrome for this cohort. These patients will undergo a baseline echocardiogram and a FAPI PET/MR scan to investigate fibrosis activity within the cardiac chambers and valves. The investigators will recruit patients with established cardiac involvement as well as carcinoid syndrome patients with high circulating 5-HT concentrations who have no evidence of valve disease on echocardiography. All patients will have a follow up cardiac MRI scan and an echocardiogram, 6 months - 1 year after their baseline scan to assess whether baseline fibrosis activity is associated with subsequent deterioration in cardiac and valvular function. Receives: Diagnostic Test: 68Ga-FAPI and 18F-AlF-FAPI PET-MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis activity: Standardised uptake values (SUV
SUV
Measured: 1-2 years
Fibrosis activity:Tissue-to-Background Ratio
TBR
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start10 Nov 2022
- Primary completion23 Jul 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Dweck, MBBS PhD, Study chair, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756608
- Sponsor's protocol ID
- 300754
- Acronym
- FCDMI
- Status last verified
- Aug 2026
- First submitted
- 18 Feb 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrosis in Chronic and Delayed Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05756608
- Acronym / sponsor ID
- FCDMI / 300754
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 6 Mar 2023 (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.
In this study the investigators aim to examine the role that fibrosis plays in heart conditions such as aortic stenosis , chemotherapy-induced cardiotoxicity and carcinoid syndrome . Fibrosis is a common final result following any injury to the heart muscle and the investigators aim to identify this process early and in its active state. This will be examined by using a radiotracer 68Ga-FAPI or 18F-AlF-FAPI and PET-MRI or PET-CT.
Detailed description
The investigators aim to investigate the role of fibrosis activity using 68Ga-FAPI and 18F-AlF-FAPI PET in chronic and delayed valvular, myocardial and endocardial injury states, in particular aortic stenosis, chemotherapy induced cardiotoxicity and carcinoid heart disease. The investigators also aim to analyse serum markers of myocardial injury and fibrosis at different time-points in these patient cohorts.
Research Hypothesis
- In patients with aortic stenosis, myocardial fibrosis activity will correlate with markers of left ventricular decompensation and aortic valve fibrosis activity, will predict progression in fibrosis burden and will decline following aortic valve replacement.
- Increased myocardial fibrosis activity will be observed in the early stages of anthracycline- induced cardiotoxicity and will predict later deterioration in cardiac function.
- In patients with carcinoid syndrome, increased endocardial fibrosis activity will be observed in patients with subclinical and clinically significant valve involvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aortic stenosis | – | Diagnostic Test: 68Ga-FAPI and 18F-AlF-FAPI PET-MRThe investigators will recruit 70 patients with aortic stenosis (25 patients with asymptomatic moderate aortic stenosis and 25 patients with symptomatic severe aortic stenosis, 10 patients with mild aortic stenosis and 10 patients with aortic sclerosis) and 10 healthy volunteers, who will undergo baseline 68Ga-FAPI or 18F-AlF-FAPI PET/MR imaging to establish fibrosis activity in healthy myocardium and in context of chronic myocardial injury. All patients will have a follow up FAPI PET/ MR scan 1 year after their baseline scan to assess whether myocardial fibrosis activity reverses following aortic valve replacement and restoration of normal afterload in patients with severe aortic stenosis and if baseline myocardial fibrosis activity can predict progression in the fibrosis burden and clinical progression in patients with mild or moderate aortic stenosis or aortic sclerosis. Healthy volunteers will not undergo any repeat imaging. |
| Chemotherapy-induced cardiotoxicity | – | Diagnostic Test: 68Ga-FAPI and 18F-AlF-FAPI PET-MRThe investigators will recruit 60 patients who have undergone anthracycline treatment >1 year from enrollment and 10 healthy volunteers as part of this cohort. This will include 50 patients who have either clear evidence of cardiotoxicity (Ejection fraction <50% and a 10%point fall in ejection fraction) or a subclinical cardiac injury (elevated troponin, elevated T2, impaired global longitudinal strain) and 10 patients with no evidence of cardiotoxicity on their cardiac MRI scan (performed as part of the ongoing Cardiac CARE study). These patients will undergo baseline FAPI PET/MR imaging to establish the extent and pattern of myocardial fibrosis activity in context of delayed myocardial injury (chemotherapy-induced cardiotoxicity). All patients will have a follow up cardiac MRI scan 1-2 years after their baseline scan to assess whether baseline fibrosis activity is associated with a deterioration in cardiac function. Healthy volunteers will not undergo any repeat imaging. |
| Carcinoid syndrome | – | Diagnostic Test: 68Ga-FAPI and 18F-AlF-FAPI PET-MRIn collaboration with the South East Scotland NET Service, the investigators will recruit 30 patients with carcinoid syndrome for this cohort. These patients will undergo a baseline echocardiogram and a FAPI PET/MR scan to investigate fibrosis activity within the cardiac chambers and valves. The investigators will recruit patients with established cardiac involvement as well as carcinoid syndrome patients with high circulating 5-HT concentrations who have no evidence of valve disease on echocardiography. All patients will have a follow up cardiac MRI scan and an echocardiogram, 6 months - 1 year after their baseline scan to assess whether baseline fibrosis activity is associated with subsequent deterioration in cardiac and valvular function. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort 1: 70 patients with aortic stenosis with 10 matched healthy volunteers Cohort 2: 60 patients with Chemotherapy-induced cardiotoxicity and 10 healthy volunteers Cohort 3: 30 patients with carcinoid syndrome
Key inclusion criteria (16 listed)
- Male or female above the age of 50 years old
- Provision of informed consent prior to any study specific procedures
- 25 patients with symptomatic severe aortic stenosis (peak velocity >4.0 m/s)
- 25 patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s)
- 10 patients with mild aortic stenosis (peak velocity 2.6-2.9 m/s)
Key exclusion criteria (7 listed)
- Inability or unwilling to give informed consent.
- History of claustrophobia or feeling of inability to tolerate supine position for the MRI scans.
- Impaired renal function with eGFR of <30 mL/min/1.73m2.
- Women who are pregnant or breastfeeding.
- Contrast allergy
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 |
|---|---|---|
| 68Ga-FAPI and 18F-AlF-FAPI PET-MRHybrid Cardiac PET-MR with 68Ga-FAPI and 18F-AlF-FAPI radiotracer | Diagnostic test | Aortic stenosis, Carcinoid syndrome, Chemotherapy-induced cardiotoxicity |
Primary outcome
Fibrosis activity: Standardised uptake values (SUV
Time frame: 1-2 years
SUV
Fibrosis activity:Tissue-to-Background Ratio
Time frame: 1-2 years
TBR
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 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Marc Dweck, MBBS PhD study chair
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Chemotherapy Induced Systolic Dysfunction, run by University of Edinburgh at 1 site 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 16 inclusion and 7 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 12 Aug 2026. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Fibrosis activity: Standardised uptake values (SUV (time frame: 1-2 years). 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 12 Aug 2026.