An observational study in Amyloidosis and Transthyretin Amyloid Cardiomyopathy, sponsored by Oregon Health and Science University. Terminated at 1 site in United States. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Oregon Health and Science University · Observational
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's enrollment of 4 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with ATTR-CM
Exclusion Criteria:
Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial
Diagnostic Test: 99m-technetium pyrophosphate scintigraphy
Imaging test
Also known as: Tc-99m PYP
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.
Time frame: 120-140 weeks
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
Time frame: 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
Time frame: 61 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University