Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05259072




Registration number
NCT05259072
Ethics application status
Date submitted
17/02/2022
Date registered
28/02/2022
Date last updated
28/02/2022

Titles & IDs
Public title
carDIo-ttranSSfOrm nucLEar Imaging Study
Scientific title
carDIo-ttranSSfOrm nucLEar Imaging Study
Secondary ID [1] 0 0
00023310
Universal Trial Number (UTN)
Trial acronym
DISSOLvE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyloidosis 0 0
Transthyretin Amyloid Cardiomyopathy 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - 99m-technetium pyrophosphate scintigraphy

Other: 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


Diagnosis / Prognosis: 99m-technetium pyrophosphate scintigraphy
Imaging test
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary outcome
Timepoint [1] 0 0
120-140 weeks
Secondary outcome [1] 0 0
Secondary outcome
Timepoint [1] 0 0
120-140 weeks
Secondary outcome [2] 0 0
Secondary outcome
Timepoint [2] 0 0
61 weeks

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- None

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Oregon

Funding & Sponsors
Primary sponsor type
Other
Name
Oregon Health and Science University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Ionis Pharmaceuticals, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05259072
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Ahmad Masri, MD MS
Address 0 0
Oregon Health and Science University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ahmad Masri, MD MS
Address 0 0
Country 0 0
Phone 0 0
503-494-8582
Fax 0 0
Email 0 0
masria@ohsu.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05259072