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Quantitative-imaging in Cardiac Transthyretin Amyloidosis

NCT05776212 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2025-06-27

No results posted yet for this study

Summary

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

Interventions

RADIATION

18F-fluoride PET

Positron emission tomography using 18F-fluoride as a tracer

Sponsors & Collaborators

  • British Heart Foundation

    collaborator OTHER

  • Netherlands Heart Foundation

    collaborator OTHER

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Marc Dweck, MD PhD · Centre of Cardiovascular Science

  • Fabien Siepen, MD PhD · Heidelberg University

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05776212 on ClinicalTrials.gov