Heart Failure With Preserved Ejection FractionCHIEFTainNCT06409585
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
An observational study of Heart Failure With Preserved Ejection Fraction and Hypertrophic Cardiomyopathy, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Heart scarring, also known as fibrosis, plays a major role in a lot of heart muscle abnormalities. These abnormalities of the heart muscle can lead to major issues such as symptoms of heart failure, dangerous heart rhythm disturbances and even death. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy, Cardiac Sarcoidosis
- What is being tested?
- 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR, Echocardiogram and Cardiac MRI
- How many people
- 290 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2023to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: As highlighted in the inclusion criteria above
Who may be able to join
- HFpEF cohort
- Male or female between 30 to 90 years old
- Provision of informed consent prior to any study specific procedures
- Patients with symptomatic heart failure with preserved ejection fraction as defined by the presence of heart failure symptoms (dyspnoea, reduced exercise tolerance, fatigue), signs (elevated jugular venous pressure, pulmonary crackles, peripheral oedema) as well as echocardiographic features (preserved left ventricular systolic function (>50%) and reduced diastolic function with septal e' <7cm/s or lateral e' <10cm/s).
- Hypertrophic cardiomyopathy cohort
- Male or female between 30 to 90 years old
Show all 45Show fewer
- Provision of informed consent prior to any study specific procedures
- Established diagnosis of hypertrophic cardiomyopathy: left ventricular wall thickness >15mm by any imaging modality without a loading condition to explain the hypertrophy OR
- Left ventricular wall thickness of >13 mm by any imaging modality in the presence of a genetic or non-genetic component, supported by other features including family history, non-cardiac symptoms, ECG changes and laboratory tests.
- Hypertensive heart disease cohort
- Male or female between 30 to 90 years old
- Provision of informed consent prior to any study specific procedures
- Diagnosis of essential hypertension for at least 1 year with evidence of left ventricular hypertrophy on echocardiography (left ventricular mass index >98 g/m2 and relative wall thickness >0.42)
- Arrhythmogenic cardiomyopathy
- Male or female between 30 to 90 years old
- Provision of informed consent prior to any study specific procedures
- Diagnosis of arrhythmogenic right ventricular cardiomyopathy based on the International Task Force 2010 criteria
- Myocarditis cohort
- Male or female between 30 to 90 years old
- Provision of informed consent prior to any study specific procedures
- Diagnosis of myocarditis in the past month defined with the following features
- Chest pain
- Evidence of pericarditis (pericardial rub, ST- segment elevation or pericardial effusion)
- Elevated serum troponin
- Unobstructed coronary arteries on coronary angiogram OR
- Cardiac magnetic resonance imaging evidence of myocarditis (subepicardial or mid-wall late gadolinium enhancement
- Takotsubo cardiomyopathy cohort
- Male or female between 30 to 90 years old
- Provision of informed consent prior to any study specific procedures
- Diagnosis of takotsubo cardiomyopathy in the past month as defined by European Society of Cardiology guidelines 2018
- Cardiac sarcoidosis cohort
- Male or female between 30 to 90 years old
- Provision of informed consent prior to any study specific procedures
- Diagnosis of cardiac sarcoidosis for at least 1 year based on expert consensus opinion with
- Histological diagnosis from a myocardial biopsy OR
- Histological diagnosis of extra-cardiac sarcoid AND
- One or more of following is present
- Steroid +/- immunosuppressant responsive cardiomyopathy or heart block
- Unexplained reduced LVEF (<40%)
- Unexplained sustained (spontaneous or induced) VT
- Mobitz type II 2nd degree heart block or 3rd degree heart block
- Patchy uptake on dedicated cardiac PET (in a pattern consistent with CS)
- Late Gadolinium Enhancement on CMR (in a pattern consistent with CS)
- Positive gallium uptake (in a pattern consistent with CS) AND
- Other causes for the cardiac manifestation(s) have been reasonably excluded
Who cannot join
- Inability or unwilling to give informed consent.
- History of claustrophobia or inability to tolerate supine position for the PET/MR or PET/CT scans.
- Impaired renal function with eGFR of <30 mL/min/1.73 m2.
- Women who are pregnant or breastfeeding.
- Iodine or gadolinium contrast allergy
- Contra-indication to CT scanning
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Edinburgh
Edinburgh, Scotland, EH16 5RR
Krithika Loganath, 07774365798, kloganat@ed.ac.uk
About this study
Heart scarring, also known as fibrosis, plays a major role in a lot of heart muscle abnormalities. These abnormalities of the heart muscle can lead to major issues such as symptoms of heart failure, dangerous heart rhythm disturbances and even death. However, a lot of these conditions are still not fully understood and treatment options are limited. We here aim to use a new radioactive dye called 68Ga-FAPI to identify patterns and the activity of heart muscle scarring. This radioactive dye is being used in humans particularly in identifying and monitoring cancers and has shown promise in identifying scarring in the heart as well. This will help us not only understand the underlying disease process and risk stratify these patients but also potentially help us develop new targeted therapies that can affect heart muscle scarring. Participants will undergo a baseline MRI scan using this new dye and a plain MRI scan will repeated 12-18 months after to see if there are any changes in the process.
- Conditions
- Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy, Cardiac Sarcoidosis, Hypertensive Heart Disease, Tako Tsubo Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy 1
- Being tested
- 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR, Echocardiogram, Cardiac MRI
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Takotsubo Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Familial, 1, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MRDiagnostic test
200MBq of the above named radiotracer will be administered for PET-MR
EchocardiogramDiagnostic test
Echocardiogram at baseline and 1 year follow-up
Cardiac MRIDiagnostic test
Cardiac MRI at 1 year
| Study group | Role | What they receive |
|---|---|---|
| Heart failure with preserved ejection fraction | Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. Receives: Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI | |
| Hypertrophic cardiomyopathy and Hypertensive heart disease | Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. Receives: Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI | |
| Cardiac Sarcoidosis | Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. Receives: Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI | |
| Arrhythmogenic cardiomyopathy | Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. Receives: Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI | |
| Myocarditis | Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. Receives: Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI | |
| Takotsubo cardiomyopathy | Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. Receives: Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardised uptake values
Measured: 1-2 years
Target-to-background ratio
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 posted10 May 2024
- Study start1 May 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409585
- Sponsor's protocol ID
- 307358
- Acronym
- CHIEFTain
- Status last verified
- Aug 2026
- First submitted
- 7 May 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other research groups
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
- ClinicalTrials.gov ID
- NCT06409585
- Acronym / sponsor ID
- CHIEFTain / 307358
- Conditions
- Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy, Cardiac Sarcoidosis, Hypertensive Heart Disease, Tako Tsubo Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy 1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 10 May 2024 (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.
Heart scarring, also known as fibrosis, plays a major role in a lot of heart muscle abnormalities. These abnormalities of the heart muscle can lead to major issues such as symptoms of heart failure, dangerous heart rhythm disturbances and even death. However, a lot of these conditions are still not fully understood and treatment options are limited. We here aim to use a new radioactive dye called 68Ga-FAPI to identify patterns and the activity of heart muscle scarring. This radioactive dye is being used in humans particularly in identifying and monitoring cancers and has shown promise in identifying scarring in the heart as well. This will help us not only understand the underlying disease process and risk stratify these patients but also potentially help us develop new targeted therapies that can affect heart muscle scarring. Participants will undergo a baseline MRI scan using this new dye and a plain MRI scan will repeated 12-18 months after to see if there are any changes in the process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Heart failure with preserved ejection fraction | – | Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR, Diagnostic Test: Echocardiogram, Diagnostic Test: Cardiac MRIParticipants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. |
| Hypertrophic cardiomyopathy and Hypertensive heart disease | – | Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR, Diagnostic Test: Echocardiogram, Diagnostic Test: Cardiac MRIParticipants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. |
| Cardiac Sarcoidosis | – | Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR, Diagnostic Test: Echocardiogram, Diagnostic Test: Cardiac MRIParticipants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. |
| Arrhythmogenic cardiomyopathy | – | Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR, Diagnostic Test: Echocardiogram, Diagnostic Test: Cardiac MRIParticipants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. |
| Myocarditis | – | Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR, Diagnostic Test: Echocardiogram, Diagnostic Test: Cardiac MRIParticipants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. |
| Takotsubo cardiomyopathy | – | Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR, Diagnostic Test: Echocardiogram, Diagnostic Test: Cardiac MRIParticipants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- As highlighted in the inclusion criteria above
Key inclusion criteria (45 listed)
- HFpEF cohort
- Male or female between 30 to 90 years old
- Provision of informed consent prior to any study specific procedures
- Patients with symptomatic heart failure with preserved ejection fraction as defined by the presence of heart failure symptoms (dyspnoea, reduced exercise tolerance, fatigue), signs (elevated jugular venous pressure, pulmonary crackles, peripheral oedema) as well as echocardiographic features (preserved left ventricular systolic function (>50%) and reduced diastolic function with septal e' <7cm/s or lateral e' <10cm/s).
- Hypertrophic cardiomyopathy cohort
Key exclusion criteria (6 listed)
- Inability or unwilling to give informed consent.
- History of claustrophobia or inability to tolerate supine position for the PET/MR or PET/CT scans.
- Impaired renal function with eGFR of <30 mL/min/1.73 m2.
- Women who are pregnant or breastfeeding.
- Iodine or gadolinium 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 or 18F-AlF-FAPI cardiac PET-MR200MBq of the above named radiotracer will be administered for PET-MR | Diagnostic test | Arrhythmogenic cardiomyopathy, Cardiac Sarcoidosis, Heart failure with preserved ejection fraction, Hypertrophic cardiomyopathy and Hypertensive heart disease, Myocarditis, Takotsubo cardiomyopathy |
| EchocardiogramEchocardiogram at baseline and 1 year follow-up | Diagnostic test | Arrhythmogenic cardiomyopathy, Cardiac Sarcoidosis, Heart failure with preserved ejection fraction, Hypertrophic cardiomyopathy and Hypertensive heart disease, Myocarditis, Takotsubo cardiomyopathy |
| Cardiac MRICardiac MRI at 1 year | Diagnostic test | Arrhythmogenic cardiomyopathy, Cardiac Sarcoidosis, Heart failure with preserved ejection fraction, Hypertrophic cardiomyopathy and Hypertensive heart disease, Myocarditis, Takotsubo cardiomyopathy |
Primary outcome
Standardised uptake values
Time frame: 1-2 years
Target-to-background ratio
Time frame: 1-2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other research groups
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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.
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 Heart Failure With Preserved Ejection Fraction and Hypertrophic Cardiomyopathy, 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 45 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardised uptake values (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 26 Aug 2026.