ACO-REALAcoramidis Use in ATTR Amyloidosis with Cardiomyopathy
This study observes adults with transthyretin amyloid cardiomyopathy to understand the clinical characteristics and treatment patterns associated with acoramidis use.
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases+1
+ Heart Diseases
+ Heart Failure
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 29, 2025
Actual date on which the first participant was enrolled.Transthyretin Amyloid Cardiomyopathy, or ATTR-CM, is a condition where a protein called transthyretin misfolds and builds up in the heart muscle, causing the heart to become stiff and leading to heart failure. There are two types of ATTR-CM: one caused by a genetic mutation and another associated with aging. The condition is often diagnosed late because its symptoms can resemble other heart issues. Acoramidis is a new medication approved for treating ATTR-CM by stabilizing the transthyretin protein, preventing harmful deposits. This study, named ACO-REAL, aims to gather real-world evidence on how acoramidis works for patients in everyday medical practice. It is conducted across 20 European countries and will involve up to 2,000 adults with either form of ATTR-CM who are beginning treatment with acoramidis. In this observational study, researchers will not change how patients are treated. Instead, they will observe patients who are receiving acoramidis as part of their regular care. The study will collect detailed information about the patients, including their demographics and medical history, to understand who is receiving the medication. It will also track how the treatment affects heart function, the ability to perform daily activities, overall health, quality of life, and the use of healthcare services like hospital visits. Additionally, safety data will be gathered to monitor how often the medication is stopped or interrupted and why. This real-world data will help improve the management and treatment of ATTR-CM, offering insights that could enhance patient care.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location