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

Launched by UNIVERSITY OF EDINBURGH · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to understand and detect scarring in heart muscle, which can cause serious heart problems like heart failure and dangerous heart rhythms. Researchers are using a special radioactive dye called 68Ga-FAPI to help identify patterns of scarring in patients with various heart conditions, including heart failure, hypertrophic cardiomyopathy, and myocarditis. By using this dye during MRI scans, the goal is to learn more about these heart diseases and potentially find better treatments in the future.

To participate in this trial, individuals must be between 30 and 90 years old and have specific heart conditions, such as heart failure with preserved ejection fraction or hypertrophic cardiomyopathy, among others. Participants will first have an MRI scan using the dye, followed by another MRI 12 to 18 months later to see if there are any changes in their heart condition. It’s important to note that those with certain health issues, such as severe kidney problems or who are pregnant, cannot participate. The information gained from this study could lead to better understanding and treatment options for those affected by heart muscle diseases.

Gender

ALL

Eligibility 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