A glowing dye could expose hidden heart scarring

NCT ID NCT06409585

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

About 290 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

30 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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  1. The places running it

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  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Edinburgh

    RECRUITING

    Edinburgh, Scotland, EH16 5RR, United Kingdom

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