A glowing dye could expose hidden heart scarring
NCT ID NCT06409585
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This study tests whether a new radioactive dye, 68Ga-FAPI, can spot active scarring in the heart muscle using PET-MR scans. Researchers will scan about 290 people with various heart muscle conditions, such as heart failure with preserved ejection fraction, hypertrophic cardiomyopathy, and myocarditis. A repeat MRI about a year later will check if scarring activity changes over time. The goal is to better understand these diseases and potentially guide future treatments that target scarring.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A radioactive dye called 68Ga-FAPI or 18F-AlF-FAPI, given as an injection for PET-MR imaging
- What this could lead to
- If successful, this could lead to better ways to detect active heart scarring, helping doctors predict risks and develop new targeted therapies for heart muscle diseases.
- What could go wrong
- This is an early imaging study, not a treatment trial. The dye's ability to track scarring changes over time is unproven, and results may not directly improve patient outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 290 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
As highlighted in the inclusion criteria above
- Ages
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30 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Edinburgh
RECRUITINGEdinburgh, Scotland, EH16 5RR, United Kingdom
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- Can GLP-1 drugs improve heart function during exercise in Obesity-Related heart failure?
- Could tiny heart vessels hold the key to a common form of heart failure?
- Can a weekly injection calm heart inflammation in sarcoidosis?