RecruitingNCT06409585

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


Sponsor

University of Edinburgh

Enrollment

290 participants

Start Date

May 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study uses advanced heart imaging (MRI and echocardiography) to better understand cardiomyopathies — diseases of the heart muscle — including heart failure with preserved ejection fraction (HFpEF) and hypertrophic cardiomyopathy (HCM). The goal is to find better ways to diagnose and monitor these conditions. **You may be eligible if...** - You are 30 to 90 years old - You have been diagnosed with heart failure with preserved ejection fraction (HFpEF) — meaning your heart pumps normally but fills poorly — or hypertrophic cardiomyopathy - You have symptoms like shortness of breath, reduced exercise tolerance, or leg swelling - You are able to provide informed consent **You may NOT be eligible if...** - You cannot undergo MRI (e.g., metallic implants, pacemaker) - You have conditions that prevent echocardiography - You are not within the specified age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR

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

DIAGNOSTIC_TESTEchocardiogram

Echocardiogram at baseline and 1 year follow-up

DIAGNOSTIC_TESTCardiac MRI

Cardiac MRI at 1 year


Locations(1)

University of Edinburgh

Edinburgh, Scotland, United Kingdom

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NCT06409585


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