Quantitative-imaging in Cardiac Transthyretin Amyloidosis

ConditionATTR-CM
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorUniversity of Edinburgh

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 18F-fluoride PET

Treatment groups

140 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Edinburgh

Lead sponsor

British Heart Foundation

Collaborator

Netherlands Heart Foundation

Collaborator

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Collaborator