8212 - Preserved - Clinical Trial
What is the Purpose of this Study?
This study has several parts. First, there is a screening period that can last up to 42 days. After that, people are randomly placed into different groups to start treatment. The main part of the study lasts 24 weeks, and doctors will check how the heart is doing at the end of that time.
If someone finishes the first part and is still taking the study medicine, they may be placed into a new group for another 24 weeks of treatment. After that, there is a safety check that lasts 12 weeks to make sure everything is okay after the medicine ends.
This study is looking at how different amounts of a medicine called CDR132L affect the heart in people who have heart failure. These people have a kind of heart problem where the heart still pumps well but is thicker than normal. Some people in the study will get the medicine, and others will get a fake pill called a placebo. The researchers want to see how the medicine changes how the heart looks and works.
Who Can Participate in the Study?
This study is for people between the ages of 40 and 84. They must have had heart failure for at least 90 days and need to take medicine to help remove extra fluid from their body. They should feel symptoms like tiredness or trouble breathing but still be able to do some daily activities.
People in the study must be taking heart medicine that has not changed for at least 45 days. Their heart must still pump well, but tests must show that the heart walls are thick and the top part of the heart is larger than normal. They must also have a healthy weight and a certain level of a substance in their blood that shows how the heart is working.
What is Involved?
The main goal of this study is to see how safe and helpful a medicine called CDR132L is for adults who have a kind of heart problem called heart failure with preserved ejection fraction. These people also have thick heart walls. The medicine will be added to the regular treatment they already get. The study includes 48 weeks of treatment, split into two parts of 24 weeks each, and then a 12-week period to check for safety after the treatment ends.
Study Details
