Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

* Patients with cardiac transthyretin amyloid * Patients with cardiac light chain amyloid * Patients with hypertrophic cardiomyopathy

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 18F-fluoride PET

    Radiation

    Positron emission tomography using 18F-fluoride as a tracer

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Work package 1 - Optimisation of 18F-fluoride PET in ATTR-CM1 intervention
Group B: Work package 2 - Differentiation ATTR-CM from phenocopies1 intervention
Group C: Work package 3 - In vivo calibration of 18F-fluoride PET1 intervention
Group D: Work package 4 - Disease progression and treatment response1 intervention

Trial outcomes

Primary outcomes

1

TBR threshold

Tissue to background ratio with a good specificity and sensitivity to differentiatie subjects with ATTR-CM from subjects with phenocopies.

Time frame
1.5 years

Secondary outcomes

1

Change in TBR

Change in TBR on 18F-fluoride PET/CT during one year of follow up.

Time frame
2.5 years
2

Change in cardiac indices on CMR

Change in cardiac indices on magnetic resonance imaging, such as left ventricular ejection fraction

Time frame
2.5 years
3

Change in cardiac biomarkers

Change in NT-ProBNP during one year of follow up.

Time frame
2.5 years
4

Change in clinical measures

Change in clinical measures such as 6-minute walk test

Time frame
2.5 years

Other outcomes

Sponsors and contacts

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University of Edinburgh

Lead sponsor

British Heart Foundation

Collaborator

Netherlands Heart Foundation

Collaborator

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Collaborator

Source ClinicalTrials.gov
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