LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2 - Clinical Trial
What is the Purpose of this Study?
This study has two parts. In the first part, people will receive either the study medicine called oral levosimendan or a placebo, which looks the same but has no medicine. During this first part, people will visit the study site about seven to ten times and have several phone calls. In the second part of the study, everyone will receive the study medicine. If someone joins the second part, they will have more study visits and phone calls. How long a person stays in the study can be different for each person. Some people may be in the study for about thirty four weeks, while others may take part for up to one hundred twelve weeks. This consent form only covers the first part of the study, and a new consent will be signed before starting the second part.
Pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF)
Who Can Participate in the Study?
People can join this study if they are between 18 and 85 years old. They must have heart failure symptoms that cause some limits with daily activities, but they are still able to walk around. They must have a condition called pulmonary hypertension with heart failure where the heart still pumps well. This diagnosis must be confirmed by a special heart test that checks blood pressure inside the heart. People cannot join if they have blood clots in their lungs. They must also be able to walk a certain distance during a six minute walking test.
What is Involved?
The purpose of this study is to find out if a medicine called levosimendan can help people who have high blood pressure in the lungs and heart failure where the heart still pumps well. The medicine is taken by mouth and is compared to a placebo, which has no medicine. Researchers want to see if levosimendan is safe and if it helps people walk farther in six minutes, which is a test used to measure how well the heart and lungs are working.
Study Details
