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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/NCT06073574




Registration number
NCT06073574
Ethics application status
Date submitted
4/10/2023
Date registered
10/10/2023
Date last updated
10/10/2023

Titles & IDs
Public title
CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
Scientific title
The CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
Secondary ID [1] 0 0
2019-002835-27
Secondary ID [2] 0 0
ION-682884-CS2MRI
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Cardiac MRI

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.


Diagnosis / Prognosis: Cardiac MRI
MRI Scans as specified in the corresponding arm group.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups
Timepoint [1] 0 0
From Baseline up to Week 140

Eligibility
Key inclusion criteria
To participate in the ION-682884-CS2MRI sub-study, participants must meet all inclusion
criteria of the study protocol ION-682884-CS2 (NCT04136171).
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Contraindication or sensitivity to MRI contrast agents

2. Orthopnea of sufficient severity to preclude supine scanning at screening.

3. Weight or body girth exceeds the limits of the cardiac MRI machine specifications.

4. Contraindication to cardiac MRI scanning, as assessed by local MRI safety
questionnaire/checklist.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
150
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
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Oregon
Country [3] 0 0
Italy
State/province [3] 0 0
Florence
Country [4] 0 0
Italy
State/province [4] 0 0
Padova
Country [5] 0 0
Spain
State/province [5] 0 0
Majadahonda
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Bellshill
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Birmingham
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Cardiff
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06073574
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries