carDIo-ttranSSfOrm nucLEar Imaging Study

Phase 3

Terminated

• Conditions: Transthyretin Amyloid Cardiomyopathy; Amyloidosis
• Interventions: Diagnostic Test: 99m-technetium pyrophosphate scintigraphy

• Registration Number: NCT05259072
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study Start: 2022-01-19
• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform	99m-technetium pyrophosphate scintigraphy	Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary outcome	61 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 week 61

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States