Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)NCT06073574
CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
An observational study of Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM), run by Ionis Pharmaceuticals, Inc. at 11 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
- What is being tested?
- Cardiac MRI
- How many people
- 160 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 31 Mar 2021to 13 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- To participate in the ION-682884-CS2MRI sub-study, participants must meet all inclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).
Who cannot join
- 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.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United Kingdom6 sites
Synexus - Scotland Clinical Research Centre
Bellshill, ML4 3NJ
Synexus Midlands Clinical Research Centre
Birmingham, B15 2SQ
Synexus - Wales
Cardiff, CF15 9SS
Royal Free London NHS Foundation Trust
London, NW3 2QG
Richmond Pharmacology
London, SE1 1YR
Synexus - Manchester Clinical Research Centre
Manchester, M15 6SE
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Oregon Health and Science University
Portland, Oregon, 97239
Italy2 sites
Azienda Ospedaliero - Universitaria Careggi
Florence, 50139
Azienda Ospedale Università di Padova
Padova, 35128
About this study
Official title: The 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).
Read the detailed description
This pilot study will determine the efficacy of ION-682284 in reducing the amyloid deposit on the heart tissue compared to placebo.
- Being tested
- Cardiac MRI
- Keywords
- TTR, Amyloidosis, Cardiomyopathy
- Medical subject headings
- Amyloidosis, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
MRI Scans as specified in the corresponding arm group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups
Measured: From Baseline up to Week 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start31 Mar 2021
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)Studies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073574
- Sponsor's protocol ID
- ION-682884-CS2MRI
- Other IDs
- 2019-002835-27, 2019
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
- ClinicalTrials.gov ID
- NCT06073574
- Acronym / sponsor ID
- ION-682884-CS2MRI
- Keywords
- TTR, Amyloidosis, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: ION-682884-CS2 MRI Scan Sub-set | – | Diagnostic Test: Cardiac MRIParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- To participate in the ION-682884-CS2MRI sub-study, participants must meet all inclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRIMRI Scans as specified in the corresponding arm group. | Diagnostic test | Experimental: ION-682884-CS2 MRI Scan Sub-set |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- CARDIO-TTransform WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM), run by Ionis Pharmaceuticals, Inc. at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, United States, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.