Active — Not RecruitingNot Applicable

The CARDIO-TTRansform Scintigraphy Sub-study

United States, Spain150 participantsStarted 2023-04-04

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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 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.

What they're measuring

Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140

Timeframe: Baseline up to Week 140

Trial details

NCT IDNCT06073587

SponsorIonis Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-03

View on ClinicalTrials.gov More Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM) trials