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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06073574
Enrollment
160
Registered
2023-10-10
Start date
2021-03-31
Completion date
2026-03-13
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Keywords

TTR, Amyloidosis, Cardiomyopathy

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.

Interventions

DIAGNOSTIC_TESTCardiac MRI

MRI Scans as specified in the corresponding arm group.

Sponsors

Ionis Pharmaceuticals, Inc.
Lead SponsorINDUSTRY
AstraZeneca
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment GroupsFrom Baseline up to Week 140

Countries

Italy, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026