Quantitative-imaging in Cardiac Transthyretin Amyloidosis

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
University Medical Centre Groningen
RECRUITING
Groningen
Contact Information
Primary
Riemer Slart, MD PhD
r.h.j.a.slart@umcg.nl
+31503611835
Time Frame
Start Date: 2021-08-25
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 140
Treatments
Work package 1 - Optimisation of 18F-fluoride PET in ATTR-CM
Optimise 18F-fluoride PET imaging of ATTR-CM with increased myocardial tissue to background ratio (TBR) uptake values to provide a state-of-the-art imaging modality for use in the other work packages. (n=15, ATTR-CM subjects)
Work package 2 - Differentiation ATTR-CM from phenocopies
Establish the optimised 18F-fluoride TBR threshold that best differentiates ATTR-CM (n=100) from phenocopies (subjects with light chain amyloidosis, n=20 and subjects with hypertrophic cardiomyopathy, n=20).
Work package 3 - In vivo calibration of 18F-fluoride PET
In vivo calibration of 18F-fluoride PET as a marker of the myocardial ATTR burden, calibrating optimised TBR values against the current imaging standard cardiac magnetic resonance imaging extracellular volume. (Subjects with ATTR-CM, n=100)
Work package 4 - Disease progression and treatment response
Establish ability of 18F-fluoride PET to track disease progression and treatment response in ATTR-CM at one year follow up. (Subjects with ATTR-CM, n=100)
Sponsors
Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Netherlands Heart Foundation, British Heart Foundation
Leads: University of Edinburgh

This content was sourced from clinicaltrials.gov