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

Sponsor: University of Edinburgh

NCT ID: NCT06409585

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR (diagnostic test), Echocardiogram (diagnostic test), Cardiac MRI (diagnostic test)
How long the study runs
Study runs about 56 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
30 Years to 90 Years
Who
All
Number of participants
290
Started
2023-05-01
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure with preserved ejection fraction
  • • Clinical study - 290 participants
  • • Heart scarring, also known as fibrosis, plays a major role in a lot of heart muscle abnormalities

Who can take part?

  • • Ages 30 Years to 90 Years
  • • Diagnosed with heart failure with preserved ejection fraction

Where?

  • • Edinburgh - University of Edinburgh

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Heart Failure With Preserved Ejection FractionHypertrophic CardiomyopathyCardiac SarcoidosisHypertensive Heart DiseaseTako Tsubo CardiomyopathyArrhythmogenic Right Ventricular Cardiomyopathy 1Myocarditis

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 30 Years - 90 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓HFpEF cohort
  • ✓Male or female between 30 to 90 years old
  • ✓Provision of agreement to take part prior to any study specific procedures
  • ✓Hypertrophic cardiomyopathy cohort
  • ✓Established diagnosis of hypertrophic cardiomyopathy: left ventricular wall thickness \>15mm by any imaging modality...

Who cannot take part

  • ✗Inability or unwilling to give agreement to take part.
  • ✗History of claustrophobia or inability to tolerate supine position for the PET/MR or PET/CT scans.
  • ✗Impaired kidney function with eGFR of \<30 mL/min/1.73 m2.
  • ✗Women who are pregnant or breastfeeding.
  • ✗Iodine or gadolinium contrast allergy
See the full criteria
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

Where Is This Study? (1 UK site)

University of Edinburgh

Edinburgh EH16 5RR, United Kingdom

Recruiting
Site contact (verified)
Data sourced from ClinicalTrials.gov · Last verified: 2026-08