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

N/AActive Not RecruitingNCT06073574

Ionis Pharmaceuticals, Inc.150 enrolled

Overview

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).

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

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Interventions

Cardiac MRIDIAGNOSTIC_TEST

MRI Scans as specified in the corresponding arm group.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (11)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Oregon Health and Science University

Portland, Oregon, United States

Azienda Ospedaliero - Universitaria Careggi

Florence, Italy

Outcomes

Primary Outcomes

Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups

Time frame: From Baseline up to Week 140

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.