Purpose of this Study
People in the study will have visits every 6 months for up to 5 years. At these visits, doctors will take blood and urine samples. At some visits, they will do a heart test called an echocardiogram and ask questions about how the person feels and their quality of life. At each visit, participants will get a medicine called Acoramidis to take two times every day.
Who Can Participate?
Eligibility
To join this study, you must have finished the ACT-EARLY study in the last 60 days and have a heart problem called ATTR-CM. You cannot join if you already have a nerve problem called ATTR-PN, if you have a different type of amyloid disease, or if you have very serious kidney disease (stage IV or V).
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a medicine called Acoramidis to see if it helps people with a heart problem called ATTR-CM. Some people also have another problem called ATTR-PN, which affects the nerves. The study will include people who were in an earlier study and were recently told they have ATTR-CM or both ATTR-CM and ATTR-PN. If someone has both problems, they can join this study for their heart, and their nerve problem will be treated by their doctor outside the study. If someone gets ATTR-PN later, they can stay in the study for their heart and still get care for their nerves outside the study.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients with Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy
Principal Investigator
Michel
Khouri
Protocol Number
PRO00118595
NCT ID
NCT07116473
Phase
III
Enrollment Status
Pending Open to Enrollment