The CARDIO-TTRansform Scintigraphy Sub-study

Ionis Pharmaceuticals

Status: Active, not recruiting

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

Treatments: Diagnostic Test: Scintigraphy scan

Study type: Observational

Funder types: Industry

Identifiers

NCT06073587

2019-002835-27 (EudraCT Number)

ION-682884-CS2-Scintigraphy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

ION-682884-CS2 Scintigraphy Subset

Description:

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.

Treatment:

Diagnostic Test: Scintigraphy scan