CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study

Ionis Pharmaceuticals

Status: Active, not recruiting

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

Treatments: Diagnostic Test: Cardiac MRI

Study type: Observational

Funder types: Industry

Identifiers

NCT06073574

ION-682884-CS2MRI

2019-002835-27 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to measure the amyloid burden, defined as extracellular volume (ECV) assessed by Magnetic Resonance Imaging (MRI) over time in a subset of up to 150 participants enrolled in ION-682884-CS2 (NCT04136171).

Full description

This pilot study will determine the efficacy of ION-682284 in reducing the amyloid deposit on the heart tissue compared to placebo.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

To participate in the ION-682884-CS2MRI sub-study, participants must meet all inclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).

Exclusion Criteria

1. Contraindication or sensitivity to MRI contrast agents
2. Orthopnea of sufficient severity to preclude supine scanning at screening.
3. Weight or body girth exceeds the limits of the cardiac MRI machine specifications.
4. Contraindication to cardiac MRI scanning, as assessed by local MRI safety questionnaire/checklist.

Trial design

150 participants in 1 patient group

Experimental: ION-682884-CS2 MRI Scan Sub-set

Description:

Participants enrolled in the parent study ION-682884-CS2 (NCT04136171) to receive either eplontersen or placebo and who consented to participate in this sub-study will undergo cardiac MRI at Baseline, Weeks 25, 49, 97 and 140.

Treatment:

Diagnostic Test: Cardiac MRI