ASCEND-ATTR - Clinical Trial
¿Cuál es el Propósito de este estudio?
Participants in this study will take a medicine called acoramidis by mouth two times each day for about three years. The study includes a screening period, a treatment period, and a follow up period after treatment ends.
During the study, participants will have regular visits so doctors can monitor their heart health and overall well being. Researchers want to learn more about the long term effects of acoramidis in people with transthyretin amyloid cardiomyopathy, a disease caused by abnormal protein buildup in the heart. The goal is to see how well the medicine works over time and how safe it is for patients.
This study is for people who have a heart disease called transthyretin amyloid cardiomyopathy. In this disease, an abnormal protein builds up in the heart over time. These protein deposits can make the heart thicker and stiffer, causing it to work less well. As the disease gets worse, it can lead to worsening heart function and symptoms such as shortness of breath, fatigue, and trouble with daily activities. Researchers are studying this condition to find better ways to slow the disease and improve heart health.
¿Quién puede participar en el Estudio?
People may be able to join this study if they are 18 to 80 years old and have a confirmed diagnosis of transthyretin amyloid cardiomyopathy, a disease caused by abnormal protein buildup in the heart. They must have signs that the disease is affecting the heart, have mild symptoms of heart failure, and be stable on their current treatment.
Participants may have used certain ATTR medicines before, but only for a limited time and they must stop those medicines before starting the study drug. They must have acceptable kidney function and meet specific heart test requirements. Participants must also agree to use effective birth control during the study if pregnancy is possible. Researchers are studying the long term effects of acoramidis on heart structure and function in people with ATTR cardiomyopathy.
¿Qué Implica?
This study is looking at the long term effects of a medicine called acoramidis in people who have transthyretin amyloid cardiomyopathy, a disease caused by abnormal protein buildup in the heart. Participants will take acoramidis by mouth two times each day for about three years.
Researchers will use special heart imaging tests to see how the heart changes over time and whether acoramidis can improve heart structure and function or slow the disease. The study will also look at how much amyloid protein is present in the heart. The goal is to better understand the long term safety and benefits of acoramidis for people with this heart condition.
Detalles del Estudio
