Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Conditions
Keywords
TTR, Amyloidosis, Cardiomyopathy
Brief summary
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).
Detailed description
This pilot study will determine the efficacy of ION-682284 in reducing the amyloid deposit on the heart tissue compared to placebo.
Interventions
MRI Scans as specified in the corresponding arm group.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups | From Baseline up to Week 140 |
Countries
Italy, Spain, United Kingdom, United States