Amyloidosis, Transthyretin Amyloid Cardiomyopathy
Conditions
Keywords
pyrophosphate scintigraphy, bone scintigraphy, eplontersen, tafamidis
Brief summary
The investigators will evaluate the change in myocardial uptake of 99m-technetium pyrophosphate (Tc-99m PYP) tracer on serial planar and SPECT imaging in patients enrolled in the CARDIO-TTRansform clinical trial (NCT04136171).
Detailed description
This is a multicenter trial of 80 subjects enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) who will undergo baseline and follow up Tc-99m PYP to assess for the change in myocardial uptake of the tracer.
Interventions
DIAGNOSTIC_TEST99m-technetium pyrophosphate scintigraphy
Imaging test
Sponsors
Ionis Pharmaceuticals, Inc.
Oregon Health and Science University
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients who were screened and eligible to be enrolled or have been already enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) and have a baseline 99m-technetium pyrophosphate planar and SPECT imaging done within 12 months prior to screening for CARDIO-TTRansform. * Patients have to meet the inclusion and
Exclusion criteria
of CARDIO-TTRansform trial to be enrolled. * Patient willing to consent for the study and undergo the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 120-140 weeks | Percentage of patients in both treatment groups with an improvement in the semi-quantitative visual grade by at least 1 grade from baseline and an improvement in the heart/contralateral ratio by at least 20% from baseline to end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome | 120-140 weeks | Change in cardiac amyloid activity on Tc-99m PYP SPECT as quantified by the target to background ratio from baseline to end of treatment |
Countries
United States
Outcome results
None listed