carDIo-ttranSSfOrm nucLEar Imaging Study

NCT05259072 | Terminated FDA Drug

• 1 other identifier: 00023310
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Amyloidosis; Transthyretin Amyloid Cardiomyopathy

Keywords

pyrophosphate scintigraphy; bone scintigraphy; eplontersen; tafamidis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Secondary outcome

  120-140 weeks

• Secondary outcome

  61 weeks

Study Arms (1)

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

Diagnostic Test: 99m-technetium pyrophosphate scintigraphy

Interventions

99m-technetium pyrophosphate scintigraphy DIAGNOSTIC_TEST

Imaging test

Also known as: Tc-99m PYP

Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ATTR-CM

You may qualify if:

• 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.

You may not qualify if:

• Patient willing to consent for the study and undergo the study procedures.
• None

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Ionis Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ahmad Masri, MD MS

  Oregon Health and Science University

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: January 19, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)