The CARDIO-TTRansform Scintigraphy Sub-study

Active, not recruiting

• Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
• Interventions: Diagnostic Test: Scintigraphy scan

• Registration Number: NCT06073587
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150 participants, after treatment with eplontersen or placebo based on scintigraphy scans performed at Week 140 using the Perugini grade score method.

Detailed Description

Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and have had a baseline scintigraphy scan will be offered the opportunity to participate in this sub-study which involves optional scintigraphy scans.

Study Timeline

• Study Start: 2023-04-04
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Participants must have been properly randomized into the ION-682884-CS2 study (NCT04136171) and should have had a baseline scintigraphy scan (99mTc-DPD, 99mTc- PYP, and 99mTc-HMDP) within 12 months prior to screening for ION-682884-CS2 with planar and SPECT or SPECT/CT images that can be read by the central reader.

Exclusion criteria:

• Must not meet any of the exclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).
• Must not have weight or body girth that exceeds the limits of the equipment specifications.
• Should not have any previously reported hypersensitivity reaction to Technetium-99m.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ION-682884-CS2 Scintigraphy Subset	Scintigraphy scan	Participants randomized in ION-682884-CS2 (NCT04136171) study to receive either eplontersen or placebo with baseline scintigraphy scan with planar and single-photon emission computerized tomography (SPECT) or SPECT with computed tomography (SPECT/CT) images will undergo an optional scintigraphy scan at Weeks 25 or 37, Week 97, and an additional scan at Week 140.

Primary Outcome Measures

Name	Time	Method
Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140	Baseline up to Week 140	The Perugini grading scale visually compares tracer uptake in the myocardium and ribs following injection of the bone tracers (99mTc-DPD, 99mTc-Pyrophosphate \[PYP\], or 99mTc-HMDP). The scale includes 4 grade classifications: Grade 0- no cardiac uptake and normal rib uptake, Grade 1- cardiac uptake which is less than rib uptake, Grade 2- cardiac uptake with intensity similar rib uptake, and Grade 3- cardiac uptake greater than rib uptake with mild or absent rib uptake. Visual scores of 2 or greater are classified as ATTR-positive and less than 2 are interpreted as ATTR-negative.

Trial Locations

Locations (5)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic Main Campus; 🇺🇸 Cleveland, Ohio, United States

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Spain

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

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States