ClinicalTrials.gg
RecruitingNCT06409585CHIEFTainUpdated Aug 26, 2026

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

An observational study in Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy and Cardiac Sarcoidosis, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 30 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by University of Edinburgh · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
290
Ages
30 Years to 90 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Heart Failure With Preserved Ejection Fraction
  • Hypertrophic Cardiomyopathy
  • Cardiac Sarcoidosis
  • Hypertensive Heart Disease
  • Tako Tsubo Cardiomyopathy
  • Arrhythmogenic Right Ventricular Cardiomyopathy 1
  • Myocarditis
03

In context

Cardiomyopathy, Hypertrophic

363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.

This study's planned enrollment of 290 is above the median of 259 across 174 observational studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Lead sponsor

University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

As highlighted in the inclusion criteria above

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

HFpEF cohort

  • Male or female between 30 to 90 years old
  • Provision of prior to any study specific procedures
  • Patients with symptomatic heart failure with preserved 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, 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 OR
    • Histological diagnosis of extra-cardiac sarcoid AND

One or more of following is present

  • +/- 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

Exclusion Criteria:

  • Inability or unwilling to give .
  • History of claustrophobia or inability to tolerate supine position for the PET/MR or PET/CT scans.
  • Impaired renal function with of \<30 mL/min/1.73 m2.
  • Women who are pregnant or breastfeeding.
  • Iodine or gadolinium contrast allergy
  • to CT scanning
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
290 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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: 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.

    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.

    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.

    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.

    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.

    Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR · Diagnostic Test: Echocardiogram · Diagnostic Test: Cardiac MRI

Interventions

  • Diagnostic test68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR

    200MBq of the above named radiotracer will be administered for PET-MR

  • Diagnostic testEchocardiogram

    Echocardiogram at baseline and 1 year follow-up

  • Diagnostic testCardiac MRI

    Cardiac MRI at 1 year

06

What researchers measure

Primary outcomes

  1. Standardised uptake values

    Time frame: 1-2 years

  2. Target-to-background ratio

    Time frame: 1-2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — No individual participant data will be shared with other research groups

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06409585
Responsible party
Sponsor
First posted
May 10, 2024
Start date
May 1, 2023
Primary completion
Aug 1, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Aug 26, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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