The CARDIO-TTRansform Scintigraphy Sub-study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-04

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ION-682884-CS2 Scintigraphy Subset

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.

Scintigraphy scan

Intervention Type DIAGNOSTIC_TEST

Scans will be performed as specified in the arm description.

Interventions

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Scintigraphy scan

Scans will be performed as specified in the arm description.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 have weight or body girth that exceeds the limits of the equipment specifications.
* Should not have any previously reported hypersensitivity reaction to Technetium-99m.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No