Back to resultscarDIo-ttranSSfOrm nucLEar Imaging Study (DISSOLvE)
Primary Purpose
Amyloidosis, Transthyretin Amyloid Cardiomyopathy
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
99m-technetium pyrophosphate scintigraphy
Sponsored by
About this trial
This is an interventional other trial for Amyloidosis focused on measuring pyrophosphate scintigraphy, bone scintigraphy, eplontersen, tafamidis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
Sites / Locations
- Oregon Health & Science UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform
Arm Description
Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT05259072
First Posted
February 17, 2022
Last Updated
February 17, 2022
Sponsor
Oregon Health and Science University
Collaborators
Ionis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05259072
Brief Title
carDIo-ttranSSfOrm nucLEar Imaging Study
Acronym
DISSOLvE
Official Title
carDIo-ttranSSfOrm nucLEar Imaging Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
Collaborators
Ionis Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis, Transthyretin Amyloid Cardiomyopathy
Keywords
pyrophosphate scintigraphy, bone scintigraphy, eplontersen, tafamidis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform
Arm Type
Other
Arm Description
Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial
Intervention Type
Diagnostic Test
Intervention Name(s)
99m-technetium pyrophosphate scintigraphy
Other Intervention Name(s)
Tc-99m PYP
Intervention Description
Imaging test
Primary Outcome Measure Information:
Title
Primary outcome
Description
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.
Time Frame
120-140 weeks
Secondary Outcome Measure Information:
Title
Secondary outcome
Description
Change in cardiac amyloid activity on Tc-99m PYP SPECT as quantified by the target to background ratio from baseline to end of treatment
Time Frame
120-140 weeks
Title
Secondary outcome
Description
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
Time Frame
61 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Masri, MD MS
Phone
503-494-8582
Email
masria@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Masri, MD MS
Organizational Affiliation
Oregon Health and Science University
Official's Role
Study Chair
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Masri, MD
Phone
503-494-8582
Email
masria@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Ahmad Masri, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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