NCT05776212Recruiting
Quantitative-imaging in Cardiac Transthyretin Amyloidosis
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 140 (estimated)
- First submitted
- 26 Jan 2023
- Start date
- 25 Aug 2021
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- University of Edinburgh
- Diseases
- Amyloidosis, Heart failure
- NCT number
- NCT05776212
- EudraCT number
- 2020-003350-72
What you commit to
- Study type: Observational
- Planned participants: 140
- From 25 Aug 2021 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of contrast allergy of adverse reactions (gadolinium)
- Contraindications to tafamidis therapy
Other illness
- NYHA Class IV heart failure
Lab values
- Renal dysfunction (eGFR ≤30 mL/min/1.73m2)
Other
- 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.
- Patients with atrial fibrillation and poor rate control.
- Contraindications to MR
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Centre Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.