Actively Recruiting
Quantitative-imaging in Cardiac Transthyretin Amyloidosis
Led by University of Edinburgh · Updated on 2025-06-27
140
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
Sponsors
U
University of Edinburgh
Lead Sponsor
B
British Heart Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Quantitative-imaging in Cardiac Transthyretin Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed informed consent
- Age over 40 years for patients with ATTR or AL cardiac amyloidosis
- Age over 30 years for patients with hypertrophic cardiomyopathy
- Diagnosed with ATTR cardiac amyloid according to Expert Consensus Recommendations
- Diagnosed with AL amyloidosis according to Expert Consensus Recommendations
- Diagnosed with hypertrophic cardiomyopathy according to European Society of Cardiology guidelines
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Women who are pregnant, breastfeeding, or of child-bearing potential without sterilization
- Renal dysfunction with eGFR less than or equal to 30 mL/min/1.73m2
- NYHA Class IV heart failure
- Patients with atrial fibrillation and poor rate control
- Contraindications to MRI
- History of allergic or adverse reactions to gadolinium contrast
- Contraindications to tafamidis therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Medical Centre Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
Research Team
R
Riemer Slart, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here