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Active, Not Recruiting

NCT Number: NCT06073587

The CARDIO-TTRansform Scintigraphy Sub-study

The purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150 participants, after treatment with eplontersen or placebo based on scintigraphy scans performed at Week 140 using the Perugini grade score method.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM) Amyloidosis Cardiomyopathies Cardiovascular Diseases Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Puerta de Hierro, Majadahonda, Spain

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About this study

Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and have had a baseline scintigraphy scan will be offered the opportunity to participate in this sub-study which involves optional scintigraphy scans.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have been properly randomized into the ION-682884-CS2 study (NCT04136171) and should have had a baseline scintigraphy scan (99mTc-DPD, 99mTc- PYP, and 99mTc-HMDP) within 12 months prior to screening for ION-682884-CS2 with planar and SPECT or SPECT/CT images that can be read by the central reader.

Exclusion criteria

  • Must not meet any of the exclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).
  • Must not have weight or body girth that exceeds the limits of the equipment specifications.
  • Should not have any previously reported hypersensitivity reaction to Technetium-99m.

Treatment and study plan

Scintigraphy scan

Diagnostic Test

Scans will be performed as specified in the arm description.

Primary outcomes

  1. Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140

    Time frame: Baseline up to Week 140

    The Perugini grading scale visually compares tracer uptake in the myocardium and ribs following injection of the bone tracers (99mTc-DPD, 99mTc-Pyrophosphate [PYP], or 99mTc-HMDP). The scale includes 4 grade classifications: Grade 0- no cardiac uptake and normal rib uptake, Grade 1- cardiac uptake which is less than rib uptake, Grade 2- cardiac uptake with intensity similar rib uptake, and Grade 3- cardiac uptake greater than rib uptake with mild or absent rib uptake. Visual scores of 2 or greater are classified as ATTR-positive and less than 2 are interpreted as ATTR-negative.

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

CARDIO-TTRansform ION-682884-CS2-Scintigraphy Sub-study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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