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

Active, not recruiting

• Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
• Interventions: Diagnostic Test: Cardiac MRI

• 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

Arm && Interventions

Group	Intervention	Description
Experimental: ION-682884-CS2 MRI Scan Sub-set	Cardiac MRI	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.

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

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

Synexus - Wales; 🇬🇧 Cardiff, United Kingdom

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Spain

Azienda Ospedale Università di Padova; 🇮🇹 Padova, Italy

Richmond Pharmacology; 🇬🇧 London, United Kingdom

Azienda Ospedaliero - Universitaria Careggi; 🇮🇹 Florence, Italy

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

Synexus - Manchester Clinical Research Centre; 🇬🇧 Manchester, United Kingdom

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