AmyloidosisDISSOLvENCT05259072
carDIo-ttranSSfOrm nucLEar Imaging Study
An observational study of Amyloidosis and Transthyretin Amyloid Cardiomyopathy, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The investigators will evaluate the change in myocardial uptake of 99m-technetium pyrophosphate (Tc-99m PYP) tracer on serial planar and SPECT imaging in patients enrolled in the CARDIO-TTRansform clinical trial (NCT04136171). Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Amyloidosis, Transthyretin Amyloid Cardiomyopathy
- What is being tested?
- 99m-technetium pyrophosphate scintigraphy
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 30 Dec 2023
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ATTR-CM
Who may be able to join
- Patients who were screened and eligible to be enrolled or have been already enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) and have a baseline 99m-technetium pyrophosphate planar and SPECT imaging done within 12 months prior to screening for CARDIO-TTRansform.
- Patients have to meet the inclusion and exclusion criteria of CARDIO-TTRansform trial to be enrolled.
- Patient willing to consent for the study and undergo the study procedures.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The investigators will evaluate the change in myocardial uptake of 99m-technetium pyrophosphate (Tc-99m PYP) tracer on serial planar and SPECT imaging in patients enrolled in the CARDIO-TTRansform clinical trial (NCT04136171).
Read the detailed description
This is a multicenter trial of 80 subjects enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) who will undergo baseline and follow up Tc-99m PYP to assess for the change in myocardial uptake of the tracer.
- Conditions
- Amyloidosis, Transthyretin Amyloid Cardiomyopathy
- Being tested
- 99m-technetium pyrophosphate scintigraphy
- Keywords
- pyrophosphate scintigraphy, bone scintigraphy, eplontersen, tafamidis
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99m-technetium pyrophosphate scintigraphyDiagnostic test
Also called Tc-99m PYP
Imaging test
| Study group | Role | What they receive |
|---|---|---|
| Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform | Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial Receives: Diagnostic Test: 99m-technetium pyrophosphate scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Percentage of patients in both treatment groups with an improvement in the semi-quantitative visual grade by at least 1 grade from baseline and an improvement in the heart/contralateral ratio by at least 20% from baseline to end of treatment.
Measured: 120-140 weeks
Secondary outcomes (2)
Secondary outcome
Change in cardiac amyloid activity on Tc-99m PYP SPECT as quantified by the target to background ratio from baseline to end of treatment
Measured: 120-140 weeks
Secondary outcome
Percentage of patients in both treatment groups with an improvement in the semi-quantitative visual grade by at least 1 grade from baseline and an improvement in the heart/contralateral ratio by at least 20% from baseline to week 61
Measured: 61 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start19 Jan 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Why it stopped: Rolled over into another study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- 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
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Ionis Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Ahmad Masri, Oregon Health and Science University
- Investigators
- Ahmad Masri, MD MS, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259072
- Sponsor's protocol ID
- 00023310
- Acronym
- DISSOLvE
- Status last verified
- Jan 2025
- First submitted
- 17 Feb 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- carDIo-ttranSSfOrm nucLEar Imaging Study
- ClinicalTrials.gov ID
- NCT05259072
- Acronym / sponsor ID
- DISSOLvE / 00023310
- Conditions
- Amyloidosis, Transthyretin Amyloid Cardiomyopathy
- Keywords
- pyrophosphate scintigraphy, bone scintigraphy, eplontersen, tafamidis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Rolled over into another study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Ionis Pharmaceuticals, Inc.
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 28 Feb 2022 (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 investigators will evaluate the change in myocardial uptake of 99m-technetium pyrophosphate (Tc-99m PYP) tracer on serial planar and SPECT imaging in patients enrolled in the CARDIO-TTRansform clinical trial (NCT04136171).
Detailed description
This is a multicenter trial of 80 subjects enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) who will undergo baseline and follow up Tc-99m PYP to assess for the change in myocardial uptake of the tracer.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform | – | Diagnostic Test: 99m-technetium pyrophosphate scintigraphyPatients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ATTR-CM
Key inclusion criteria (3 listed)
- Patients who were screened and eligible to be enrolled or have been already enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) and have a baseline 99m-technetium pyrophosphate planar and SPECT imaging done within 12 months prior to screening for CARDIO-TTRansform.
- Patients have to meet the inclusion and exclusion criteria of CARDIO-TTRansform trial to be enrolled.
- Patient willing to consent for the study and undergo the study procedures.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| 99m-technetium pyrophosphate scintigraphyAlso: Tc-99m PYPImaging test | Diagnostic test | Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform |
Primary outcome
Primary outcome
Time frame: 120-140 weeks
Percentage of patients in both treatment groups with an improvement in the semi-quantitative visual grade by at least 1 grade from baseline and an improvement in the heart/contralateral ratio by at least 20% from baseline to end of treatment.
2 secondary outcomes
Secondary outcome
Time frame: 120-140 weeks
Secondary outcome
Time frame: 61 weeks
Results and safety
The study was stopped early (reason given: Rolled over into another study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Ahmad Masri, MD MS study chair
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidosis and Transthyretin Amyloid Cardiomyopathy, run by Oregon Health and Science University at 1 site in United States.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Rolled over into another study). Results are not available in the source record.
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?
Primary outcome (time frame: 120-140 weeks). 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 29 Jan 2025.