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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

150

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach

4 countries

11 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

Study Start

First participant enrolled

March 31, 2021

Completed

2.5 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

4.9 years

First QC Date

October 4, 2023

Last Update Submit

November 25, 2025

Conditions

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Keywords

TTRAmyloidosisCardiomyopathy

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Experimental: ION-682884-CS2 MRI Scan Sub-set

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.

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRIDIAGNOSTIC_TEST

MRI Scans as specified in the corresponding arm group.

Experimental: ION-682884-CS2 MRI Scan Sub-set

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and who signed informed consent for the MRI sub-study will participate in this sub-study.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Ionis Pharmaceuticals, Inc.lead
AstraZenecacollaborator

Study Sites (11)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Azienda Ospedaliero - Universitaria Careggi

Florence, 50139, Italy

Location

Azienda Ospedale Università di Padova

Padua, 35128, Italy

Location

Hospital Universitario Puerta de Hierro

Majadahonda, 28222, Spain

Location

Synexus - Scotland Clinical Research Centre

Bellshill, ML4 3NJ, United Kingdom

Location

Synexus Midlands Clinical Research Centre

Birmingham, B15 2SQ, United Kingdom

Location

Synexus - Wales

Cardiff, CF15 9SS, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Richmond Pharmacology

London, SE1 1YR, United Kingdom

Location

Synexus - Manchester Clinical Research Centre

Manchester, M15 6SE, United Kingdom

Location

MeSH Terms

Conditions

AmyloidosisCardiomyopathies

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 10, 2023

Study Start

March 31, 2021

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing: Will not share

Locations

ES(1)GB(6)IT(2)US(2)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Experimental: ION-682884-CS2 MRI Scan Sub-set

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Experimental: ION-682884-CS2 MRI Scan Sub-set

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Data Sharing

Locations