carDIo-ttranSSfOrm nucLEar Imaging Study (DISSOLvE)

Oregon Health & Science University (OHSU)

Status and phase: Terminated; Phase 3

Conditions: Transthyretin Amyloid Cardiomyopathy; Amyloidosis

Treatments: Diagnostic Test: 99m-technetium pyrophosphate scintigraphy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05259072

00023310

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform

Description:

Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial

Treatment:

Diagnostic Test: 99m-technetium pyrophosphate scintigraphy