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RECRUITING
NCT05776212

Quantitative-imaging in Cardiac Transthyretin Amyloidosis

Sponsor: University of Edinburgh

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

140

Start Date

2021-08-25

Completion Date

2026-09-30

Last Updated

2025-06-27

Healthy Volunteers

No

Conditions

Interventions

RADIATION

18F-fluoride PET

Positron emission tomography using 18F-fluoride as a tracer

Locations (1)

University Medical Centre Groningen

Groningen, Netherlands