ACO-SWITCHAcoramidis Impact on Serum Transthyretin Levels in ATTR-CM Patients Previously Treated with Tafamidis
This study aims to evaluate the impact of Acoramidis on serum Transthyretin levels in patients previously treated with Tafamidis for ATTR-CM, measuring changes from the start of the study up to the sixth month or premature end of treatment.
Acoramidis
Treatment Study
Summary
Study start date: February 13, 2026
Actual date on which the first participant was enrolled.This study focuses on a condition called Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM), where a protein called Transthyretin (TTR) breaks down and forms harmful clumps in the heart, affecting its ability to pump blood effectively. This can be due to aging (wild-type ATTR-CM) or genetics (variant ATTR-CM). The study uses a drug called acoramidis, which helps stabilize the TTR protein to prevent it from breaking down and forming these clumps. The main goal of this research is to understand how switching from another similar drug, tafamidis, to acoramidis affects the levels of TTR in the blood of adults with ATTR-CM who were previously treated with tafamidis. During the study, participants will continue taking tafamidis during the screening period, and then switch to acoramidis, taking two tablets twice daily by mouth for up to 6 months. The change in TTR protein levels in the blood will be measured after 6 months of treatment with acoramidis, or earlier if a participant stops the treatment before reaching that point. Participants will have regular check-ups, including heart function tests, blood and urine samples, and health monitoring. The study involves 9 check-ins, with 2 visits to the study site, 6 home visits by a study nurse, and a final check-in by phone. Each participant may be involved in the study for about 8 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
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.From 18 to 90 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.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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 5 locations
Universitätsklinikum St. Pölten - Lilienfeld - Klinische Abteilung für Innere Medizin 3
Sankt Pölten, AustriaOpen Universitätsklinikum St. Pölten - Lilienfeld - Klinische Abteilung für Innere Medizin 3 in Google MapsMedizinische Universität Graz- Klinische Abteilung für Kardiologie
Vienna, AustriaMedizinische Universität Wien- Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie
Vienna, AustriaKlinik Favoriten - 5.Medizinische Abteilung-Kardiologie
Vienna, Austria