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Quantitative-imaging in Cardiac Transthyretin Amyloidosis

Recruitingn/aAges 40 Years - anyAllUniversity of Edinburgh
NCT05776212 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-fluor

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📋 Eligibility rules (as published)
Inclusion Criteria: * Completion of informed consent * Age \> 40 years for patients with ATTR or AL cardiac amyloidosis and age \>30 years for patients with HCM * ATTR cardiac amyloid according to Expert Consensus Recommendations * AL amyloidosis according to Expert Consensus Recommendations * Hypertrophic cardiomyopathy according to European Society of Cardiology guidelines Exclusion Criteria: * Inability or unwilling to give informed consent * Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial. * Renal dysfunction (eGFR ≤30 mL/min/1.73m2) * NYHA Class IV heart failure * Patients with atrial fibrillation and poor rate control. * Contraindications to MR * Previous history of contrast allergy of adverse reactions (gadolinium) * Contraindications to tafamidis therapy
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What it tests

  • 18F-fluoride PET
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Where

1 site
University Medical Centre Groningen
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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