Status:
ACTIVE_NOT_RECRUITING
CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Collaborating Sponsors:
AstraZeneca
Conditions:
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Eligibility:
All Genders
18-90 years
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 enro...
Detailed Description
This pilot study will determine the efficacy of ION-682284 in reducing the amyloid deposit on the heart tissue compared to placebo.
Eligibility Criteria
Inclusion
- 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
- Contraindication or sensitivity to MRI contrast agents
- Orthopnea of sufficient severity to preclude supine scanning at screening.
- Weight or body girth exceeds the limits of the cardiac MRI machine specifications.
- Contraindication to cardiac MRI scanning, as assessed by local MRI safety questionnaire/checklist.
Exclusion
Key Trial Info
Start Date :
March 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06073574
Start Date
March 31 2021
End Date
April 1 2026
Last Update
November 28 2025
Active Locations (11)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Oregon Health and Science University
Portland, Oregon, United States, 97239
3
Azienda Ospedaliero - Universitaria Careggi
Florence, Italy, 50139
4
Azienda Ospedale Università di Padova
Padua, Italy, 35128