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

NCT06409585 | Recruiting

• 1 other identifier: 307358
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure With Preserved Ejection Fraction; Hypertrophic Cardiomyopathy; Cardiac Sarcoidosis; Hypertensive Heart Disease; Tako Tsubo Cardiomyopathy; Arrhythmogenic Right Ventricular Cardiomyopathy 1; Myocarditis

Outcome Measures

Primary Outcomes (2)

• Standardised uptake values

  1-2 years

• Target-to-background ratio

  1-2 years

Study Arms (6)

Heart failure with preserved ejection fraction

Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later.

Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI

Hypertrophic cardiomyopathy and Hypertensive heart disease

Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later.

Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI

Cardiac Sarcoidosis

Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later.

Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI

Arrhythmogenic cardiomyopathy

Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later.

Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI

Myocarditis

Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later.

Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI

Takotsubo cardiomyopathy

Participants will undergo baseline echocardiography and hybrid cardiac PET-MR with 200MBq of 68Ga-FAPI or 18F-AlF-FAPI. A follow-up echocardiogram and cardiac MRI will be undertaken a year later.

Diagnostic Test: 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac MRI

Interventions

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

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

Arrhythmogenic cardiomyopathy; Cardiac Sarcoidosis; Heart failure with preserved ejection fraction; Hypertrophic cardiomyopathy and Hypertensive heart disease; Myocarditis; Takotsubo cardiomyopathy

Echocardiogram DIAGNOSTIC_TEST

Echocardiogram at baseline and 1 year follow-up

Arrhythmogenic cardiomyopathy; Cardiac Sarcoidosis; Heart failure with preserved ejection fraction; Hypertrophic cardiomyopathy and Hypertensive heart disease; Myocarditis; Takotsubo cardiomyopathy

Cardiac MRI DIAGNOSTIC_TEST

Cardiac MRI at 1 year

Arrhythmogenic cardiomyopathy; Cardiac Sarcoidosis; Heart failure with preserved ejection fraction; Hypertrophic cardiomyopathy and Hypertensive heart disease; Myocarditis; Takotsubo cardiomyopathy

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

As highlighted in the inclusion criteria above

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, Scotland, EH16 5RR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Takotsubo Cardiomyopathy; Arrhythmogenic Right Ventricular Dysplasia, Familial, 1; Myocarditis

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: May 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)