Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)NCT06073587
The CARDIO-TTRansform Scintigraphy Sub-study
An observational study of Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM), run by Ionis Pharmaceuticals, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150 participants, after treatment with eplontersen or placebo based on scintigraphy scans performed at Week 140 using the Perugini grade score… 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?
- Scintigraphy scan
- How many people
- 163 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 4 Apr 2023to 25 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 Scintigraphy sub-study will participate in this sub-study.
Who may be able to join
- Participants must have been properly randomized into the ION-682884-CS2 study (NCT04136171) and should have had a baseline scintigraphy scan (99mTc-DPD, 99mTc- PYP, and 99mTc-HMDP) within 12 months prior to screening for ION-682884-CS2 with planar and SPECT or SPECT/CT images that can be read by the central reader.
Who cannot join
- Must not meet any of the exclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).
- Must not have weight or body girth that exceeds the limits of the equipment specifications.
- Should not have any previously reported hypersensitivity reaction to Technetium-99m.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
Columbia University Irving Medical Center
New York, New York, 10032
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: CARDIO-TTRansform ION-682884-CS2-Scintigraphy Sub-study
The purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150 participants, after treatment with eplontersen or placebo based on scintigraphy scans performed at Week 140 using the Perugini grade score method.
Read the detailed description
Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and have had a baseline scintigraphy scan will be offered the opportunity to participate in this sub-study which involves optional scintigraphy scans.
- Being tested
- Scintigraphy scan
- 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.
Scintigraphy scanDiagnostic test
Scans will be performed as specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| ION-682884-CS2 Scintigraphy Subset | Participants randomized in ION-682884-CS2 (NCT04136171) study to receive either eplontersen or placebo with baseline scintigraphy scan with planar and single-photon emission computerized tomography (SPECT) or SPECT with computed tomography (SPECT/CT) images will undergo an optional scintigraphy scan at Weeks 25 or 37, Week 97, and an additional scan at Week 140. Receives: Diagnostic Test: Scintigraphy scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140
The Perugini grading scale visually compares tracer uptake in the myocardium and ribs following injection of the bone tracers (99mTc-DPD, 99mTc-Pyrophosphate [PYP], or 99mTc-HMDP). The scale includes 4 grade classifications: Grade 0- no cardiac uptake and normal rib uptake, Grade 1- cardiac uptake which is less than rib uptake, Grade 2- cardiac uptake with intensity similar rib uptake, and Grade 3- cardiac uptake greater than rib uptake with mild or absent rib uptake. Visual scores of 2 or greater are classified as ATTR-positive and less than 2 are interpreted as ATTR-negative.
Measured: 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 start4 Apr 2023
- Primary completion25 Mar 2026
- Study completion25 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
- 163 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
- NCT06073587
- Sponsor's protocol ID
- ION-682884-CS2-Scintigraphy
- Other IDs
- 2019-002835-27, 2019
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2023
- Last updated
- 11 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARDIO-TTRansform ION-682884-CS2-Scintigraphy Sub-study
- ClinicalTrials.gov ID
- NCT06073587
- Acronym / sponsor ID
- ION-682884-CS2-Scintigraphy
- Keywords
- TTR, Amyloidosis, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 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 purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150 participants, after treatment with eplontersen or placebo based on scintigraphy scans performed at Week 140 using the Perugini grade score method.
Detailed description
Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and have had a baseline scintigraphy scan will be offered the opportunity to participate in this sub-study which involves optional scintigraphy scans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ION-682884-CS2 Scintigraphy Subset | – | Diagnostic Test: Scintigraphy scanParticipants randomized in ION-682884-CS2 (NCT04136171) study to receive either eplontersen or placebo with baseline scintigraphy scan with planar and single-photon emission computerized tomography (SPECT) or SPECT with computed tomography (SPECT/CT) images will undergo an optional scintigraphy scan at Weeks 25 or 37, Week 97, and an additional scan at Week 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 Scintigraphy sub-study will participate in this sub-study.
Key inclusion criteria (1 listed)
- Participants must have been properly randomized into the ION-682884-CS2 study (NCT04136171) and should have had a baseline scintigraphy scan (99mTc-DPD, 99mTc- PYP, and 99mTc-HMDP) within 12 months prior to screening for ION-682884-CS2 with planar and SPECT or SPECT/CT images that can be read by the central reader.
Key exclusion criteria (3 listed)
- Must not meet any of the exclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).
- Must not have weight or body girth that exceeds the limits of the equipment specifications.
- Should not have any previously reported hypersensitivity reaction to Technetium-99m.
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 |
|---|---|---|
| Scintigraphy scanScans will be performed as specified in the arm description. | Diagnostic test | ION-682884-CS2 Scintigraphy Subset |
Primary outcome
Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140
Time frame: Baseline up to Week 140
The Perugini grading scale visually compares tracer uptake in the myocardium and ribs following injection of the bone tracers (99mTc-DPD, 99mTc-Pyrophosphate [PYP], or 99mTc-HMDP). The scale includes 4 grade classifications: Grade 0- no cardiac uptake and normal rib uptake, Grade 1- cardiac uptake which is less than rib uptake, Grade 2- cardiac uptake with intensity similar rib uptake, and Grade 3- cardiac uptake greater than rib uptake with mild or absent rib uptake. Visual scores of 2 or greater are classified as ATTR-positive and less than 2 are interpreted as ATTR-negative.
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 11 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.
5 sites in 2 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 5 sites in 2 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 3 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 11 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 5 sites in United States, 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?
Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140 (time frame: 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 11 Sep 2026.