Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition (CHIEFTain)

August 18, 2025 updated by: University of Edinburgh
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 5RR
        • Recruiting
        • University of Edinburgh
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

As highlighted in the inclusion criteria above

Description

Inclusion Criteria:

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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Cardiac MRI
Cardiac MRI at 1 year
Diagnostic test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR
200MBq of the above named radiotracer will be administered for PET-MR
Diagnostic test: Echocardiogram
Echocardiogram at baseline and 1 year follow-up
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.
Diagnostic test: Cardiac MRI
Cardiac MRI at 1 year
Diagnostic test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR
200MBq of the above named radiotracer will be administered for PET-MR
Diagnostic test: Echocardiogram
Echocardiogram at baseline and 1 year follow-up
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.
Diagnostic test: Cardiac MRI
Cardiac MRI at 1 year
Diagnostic test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR
200MBq of the above named radiotracer will be administered for PET-MR
Diagnostic test: Echocardiogram
Echocardiogram at baseline and 1 year follow-up
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.
Diagnostic test: Cardiac MRI
Cardiac MRI at 1 year
Diagnostic test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR
200MBq of the above named radiotracer will be administered for PET-MR
Diagnostic test: Echocardiogram
Echocardiogram at baseline and 1 year follow-up
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.
Diagnostic test: Cardiac MRI
Cardiac MRI at 1 year
Diagnostic test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR
200MBq of the above named radiotracer will be administered for PET-MR
Diagnostic test: Echocardiogram
Echocardiogram at baseline and 1 year follow-up
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.
Diagnostic test: Cardiac MRI
Cardiac MRI at 1 year
Diagnostic test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR
200MBq of the above named radiotracer will be administered for PET-MR
Diagnostic test: Echocardiogram
Echocardiogram at baseline and 1 year follow-up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Standardised uptake values
Time Frame: 1-2 years
1-2 years
Target-to-background ratio
Time Frame: 1-2 years
1-2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 307358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared with other research groups

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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