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

Active, not recruiting

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

• Registration Number: NCT06073574
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

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.

Study Timeline

• Study Start: 2021-03-31
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

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

Azienda Ospedale Università di Padova; 🇮🇹 Padova, Italy

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Spain

Synexus - Scotland Clinical Research Centre; 🇬🇧 Bellshill, United Kingdom

Synexus Midlands Clinical Research Centre; 🇬🇧 Birmingham, United Kingdom

Synexus - Wales; 🇬🇧 Cardiff, United Kingdom

Royal Free London NHS Foundation Trust; 🇬🇧 London, United Kingdom

Richmond Pharmacology; 🇬🇧 London, United Kingdom

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