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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-90
SponsorUniversity of Edinburgh

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Male or female between 30 to 90 years old

Disqualifiers

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.

Trial population

As highlighted in the inclusion criteria above

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR

    Diagnostic test

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

  • Echocardiogram

    Diagnostic test

    Echocardiogram at baseline and 1 year follow-up

  • Cardiac MRI

    Diagnostic test

    Cardiac MRI at 1 year

Treatment groups

290 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Heart failure with preserved ejection fraction3 interventions
Group B: Hypertrophic cardiomyopathy and Hypertensive heart disease3 interventions
Group C: Cardiac Sarcoidosis3 interventions
Group D: Arrhythmogenic cardiomyopathy3 interventions
Group E: Myocarditis3 interventions
Group F: Takotsubo cardiomyopathy3 interventions

Trial outcomes

Primary outcomes

1

Standardised uptake values

Time frame
1-2 years
2

Target-to-background ratio

Time frame
1-2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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