Clinical Trial
Study Details
Status
RECRUITING
Study ID #
NCT05259072
Study Start
Primary Completion
Study Completion
Enrollment
80
Study Type
Interventional
Phase
Phase 3
Interventions
99m-technetium pyrophosphate scintigraphy

Imaging test

Primary Outcomes
Measure
Primary outcome
Description

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.

Timeframe
120-140 weeks
Secondary Outcomes
Measure
Secondary outcome
Description

Change in cardiac amyloid activity on Tc-99m PYP SPECT as quantified by the target to background ratio from baseline to end of treatment

Timeframe
120-140 weeks
Measure
Secondary outcome
Description

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

Timeframe
61 weeks
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).

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.

Conditions
Amyloidosis
Transthyretin Amyloid Cardiomyopathy
Study Contact
Name
Ahmad Masri, MD MS
Role
Contact
Phone
503-494-8582
Email
masria@ohsu.edu
Locations
Facility

Oregon Health & Science University
Portland, OR 97239
United States

Contacts
Study Contact
Name
Ahmad Masri, MD
Role
Principal Investigator
Eligibility Criteria

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

Eligibility Minimum Age
60 Years
Eligibility Maximum Age
90 Years
Sexes Eligible for Study
ALL
Eligibility Std Ages
Adult
Older Adult