Using advanced imaging to evaluate heart muscle scarring in various heart conditions
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
This study is testing a new imaging method to see how heart scarring changes over time in people with certain heart conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 290 (estimated) |
| Ages | 30 Years to 90 Years |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh, Scotland) |
| Trial ID | NCT06409585 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the patterns and activity of myocardial fibrosis, or heart scarring, in patients with conditions such as heart failure with preserved ejection fraction and hypertrophic cardiomyopathy. Participants will receive a baseline cardiac MRI scan using a new radioactive dye called 68Ga-FAPI, which has shown promise in identifying heart scarring. A follow-up MRI will be conducted 12-18 months later to assess any changes in the heart muscle. The findings may enhance understanding of these heart conditions and contribute to the development of targeted therapies.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 30 to 90 with symptomatic heart failure with preserved ejection fraction or diagnosed hypertrophic cardiomyopathy.
Not a fit: Patients with conditions not related to heart muscle scarring or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment options for patients with heart muscle diseases.
How similar studies have performed: Other studies using advanced imaging techniques for cardiac evaluation have shown promise, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
Edinburgh, Scotland
- University of Edinburgh — Edinburgh, Scotland, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.