Skip to main content
MedPathMedPath Home
Clinical Trials/NCT06073574
NCT06073574
Active, not recruiting
Not Applicable

The CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study

Ionis Pharmaceuticals, Inc.11 sites in 4 countries150 target enrollmentMarch 31, 2021
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsTransthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Sponsor
Ionis Pharmaceuticals, Inc.
Enrollment
150
Locations
11
Primary Endpoint
Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups
Status
Active, not recruiting
Last Updated
5 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Detailed Description

This pilot study will determine the efficacy of ION-682284 in reducing the amyloid deposit on the heart tissue compared to placebo.

Registry
clinicaltrials.gov
Start Date
March 31, 2021
End Date
April 1, 2026
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).
  • •Exclusion Criteria
  • •Contraindication or sensitivity to MRI contrast agents
  • •Orthopnea of sufficient severity to preclude supine scanning at screening.
  • •Weight or body girth exceeds the limits of the cardiac MRI machine specifications.
  • •Contraindication to cardiac MRI scanning, as assessed by local MRI safety questionnaire/checklist.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups

Time Frame: From Baseline up to Week 140

Study Sites (11)

Loading locations...

Similar Trials

Recruiting
Not Applicable
Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO)ATTR AmyloidosisCardiopathyCarpal Tunnel SyndromeLumbar Spine StenosisHip ProsthesisKnee Prosthesis
NCT06367842Institut Mutualiste Montsouris150
Recruiting
Not Applicable
Quantitative-imaging in Cardiac Transthyretin AmyloidosisATTR-CM
NCT05776212University of Edinburgh140
Suspended
Phase 1
Positron Emission Tomography of Amyloid in Alzheimer's DiseaseAlzheimer's Disease
NCT00205621Amsterdam UMC, location VUmc50
Active, not recruiting
Not Applicable
The CARDIO-TTRansform Scintigraphy Sub-studyTransthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
NCT06073587Ionis Pharmaceuticals, Inc.150
Withdrawn
Not Applicable
Natural History of Duchenne Muscular Dystrophy Cardiomyopathy (DMD-CMP)Duchenne Muscular Dystrophy
NCT05558813Assistance Publique - Hôpitaux de Paris150