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The CARDIO-TTRansform Scintigraphy Sub-study

Active Not RecruitingN/A

Sponsor: Ionis Pharmaceuticals, Inc.

Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Interventions: Scintigraphy scan

Countries: United States, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (5)

New York, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Majadahonda, Spain