RecruitingNCT05776212

Quantitative-imaging in Cardiac Transthyretin Amyloidosis


Sponsor

University of Edinburgh

Enrollment

140 participants

Start Date

Aug 25, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Transthyretin amyloid cardiomyopathy (ATTR-CM), is a heart muscle disease that's stops the heart muscle working properly. With an ageing population, it is increasingly common but untreated, it has a poor prognosis. Several novel expensive treatments have become available, although we do not understand exactly how they work and why some patients respond, and others do not. The challenge is to develop better methods for monitoring the effects of these treatments, maximizing their benefits and cost-effectiveness. In I-CARE we aim to bring a new imaging technique, named 18F-fluoride PET, to the clinic and thereby improve the care of patients with ATTR-CM. Hypotheses: 1. A delayed imaging protocol and state-of-the-art PET motion correction will optimise 18F-fluoride imaging in ATTR-CM and provide a clear threshold in myocardial TBR values for the diagnosis of ATTR-CM. 2. Optimised 18F-fluoride PET will provide a quantitative marker of the ATTR-CM burden that will allow disease progression and treatment response to be tracked. 3. Myocardial 18F-fluoride TBR values will reduce in patients responding to tafamidis treatment and increase in non-responders and patients not receiving therapy


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is using advanced imaging tools to better measure and understand two conditions that cause thickening and stiffening of the heart muscle: cardiac amyloidosis (where abnormal proteins called amyloid build up in the heart) and hypertrophic cardiomyopathy (HCM, a genetic thickening of the heart muscle). The goal is to improve how these conditions are diagnosed and monitored over time. **You may be eligible if...** - You are over 40 with confirmed ATTR or AL cardiac amyloidosis (protein buildup in the heart) - You are over 30 with hypertrophic cardiomyopathy (HCM) - Your diagnosis meets established expert consensus guidelines **You may NOT be eligible if...** - You are pregnant, breastfeeding, or a woman of childbearing potential (unless surgically sterile or postmenopausal) - You are unable or unwilling to give informed consent Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATION18F-fluoride PET

Positron emission tomography using 18F-fluoride as a tracer


Locations(1)

University Medical Centre Groningen

Groningen, Netherlands

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NCT05776212


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