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Rolled over into another study
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| Name | Class |
|---|---|
| Ionis Pharmaceuticals, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform | Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99m-technetium pyrophosphate scintigraphy | Diagnostic Test | Imaging test |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with ATTR-CM
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad Masri, MD MS | Oregon Health and Science University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 61 weeks |