carDIo-ttranSSfOrm nucLEar Imaging Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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carDIo-ttranSSfOrm nucLEar Imaging Study

Conditions
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Amyloidosis, Transthyretin Amyloid Cardiomyopathy

Intervention / Treatment
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* Diagnostic Test: 99m-technetium pyrophosphate scintigraphy


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform<br>Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial | Diagnostic Test: 99m-technetium pyrophosphate scintigraphy<br>* Imaging test<br>* Other names: Tc-99m PYP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome | 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. | 120-140 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome | Change in cardiac amyloid activity on Tc-99m PYP SPECT as quantified by the target to background ratio from baseline to end of treatment | 120-140 weeks | 
| Secondary outcome | 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 week 61 | 61 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eplontersen, pyrophosphate scintigraphy, bone scintigraphy, tafamidis