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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM) Amyloidosis Cardiomyopathies Cardiovascular Diseases Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero - Universitaria Careggi, Florence, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac MRI

Diagnostic Test

MRI Scans as specified in the corresponding arm group.

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

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Collaborators

AstraZeneca

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Oct 10, 2023
Registry last updated: Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting