Transthyretin Amyloid Cardiomyopathy Clinical Trial

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

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).

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Full Description

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

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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.

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Estimated Enrollment:

150

Study ID:

NCT06073574

Recruitment Status:

Active, not recruiting

Sponsor:

Ionis Pharmaceuticals, Inc.

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There are 11 Locations for this study

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Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Azienda Ospedaliero - Universitaria Careggi
Florence , 50139, Italy
Azienda Ospedale Università di Padova
Padova , 35128, Italy
Hospital Universitario Puerta de Hierro
Majadahonda , 28222, Spain
Synexus - Scotland Clinical Research Centre
Bellshill , ML4 3, United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham , B15 2, United Kingdom
Synexus - Wales
Cardiff , CF15 , United Kingdom
Royal Free London NHS Foundation Trust
London , NW3 2, United Kingdom
Richmond Pharmacology
London , SE1 1, United Kingdom
Synexus - Manchester Clinical Research Centre
Manchester , M15 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Estimated Enrollment:

150

Study ID:

NCT06073574

Recruitment Status:

Active, not recruiting

Sponsor:


Ionis Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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