KINSHIP-DCM - Clinical Trial
What is the Purpose of this Study?
This study has two parts. The first part includes about eighty people, and the second part includes about two hundred fifty people. Each part of the study lasts about thirty six weeks. The study begins with screening to see if someone can join. Then there is a short period where everyone first takes a placebo and then a short period where everyone takes the study medicine. After that, people are placed by chance into groups to take either the study medicine or a placebo for about twenty four weeks. At the end, there is a follow up period where doctors check safety. Each person will join only one part of the study.
This study is testing a medicine called danicamtiv to see if it is safe and helps people who have a heart condition called genetic or familial dilated cardiomyopathy. In this condition, the heart becomes weak and stretched, which makes it hard to pump blood. The study compares danicamtiv to a placebo, which has no medicine, to see which works better. Doctors and participants will not know who is getting the real medicine during the study. The goal is to learn if danicamtiv can help people feel better and protect their heart health.
Who Can Participate in the Study?
People can join this study if they are 18 years or older and have a heart disease called dilated cardiomyopathy that runs in their family or is caused by certain genetic changes. This condition makes the heart weak and enlarged. Their heart must pump less strongly than normal, with an ejection fraction of 45 percent or lower. They must be taking standard heart failure medicines at steady doses and have been feeling stable for at least one month. Their heart condition must not be caused by things like heavy alcohol use, certain cancer treatments, pregnancy related heart problems, infections, or other temporary conditions. The heart rhythm must allow doctors to do heart scans. Participants must also be able to complete an exercise test that shows their heart function is reduced compared to healthy people.
What is Involved?
The goal of this study is to see if a medicine called danicamtiv is safe and works better than a placebo for people who have a type of heart disease called genetic or familial dilated cardiomyopathy. The medicine will be taken twice each day. The study will check how the body handles the medicine, how safe it is, and if it helps improve heart health.
The study has two main parts and two groups in each part. About eighty people will take part in the first part, and about two hundred fifty people will take part in the second part. Each person will be placed into one group, and the same group assignments will be used in both parts of the study.
Study Details
