ELEVATE-HFpEF - Clinical Trial
What is the Purpose of this Study?
In this study, people will get a special Medtronic pacemaker placed in their chest. This pacemaker uses special settings to test whether a pacing rate based on each person’s body and heart helps improve heart failure symptoms. After the device is placed, people are put into one of two groups by chance. One group gets personalized pacing based on their height and heart function. The other group gets very little pacing, used only as a backup if the heart rate drops too low. Most people and study staff will not know which group they are in during the first year so the results stay fair.
People will return for checkups at 2, 6, 12, 14, 18, and 24 months, and then once a year. At these visits, they may have heart images, blood tests, ECGs, questionnaires, a six minute walk test, and pacemaker checks. After the 12 month visit, everyone in the group with minimal pacing will switch to personalized pacing, and the study will continue to check safety and benefits.
This study is for people who have a type of heart failure called HFpEF. In this condition, the heart squeezes well but has trouble relaxing and filling with blood. People can join if they are 40 years or older, have an ejection fraction of 50 percent or higher, and have symptoms like feeling short of breath when moving around. They must also have had a recent heart failure problem, such as a hospital visit, or have ongoing symptoms. They also need at least one test showing that their heart is under strain, such as lung fluid on an image, high NT proBNP levels, high pressure found during a heart test, or an echocardiogram showing thick heart walls or a larger left atrium.
Who Can Participate in the Study?
People can join this study if they are 40 years or older and have HFpEF, which means their heart pumps well with a strength of 50 percent or higher. They must have recent or ongoing heart failure symptoms, like getting short of breath when they are active. They also need at least one test that shows their heart is under strain, such as fluid in the lungs, high NT proBNP levels, or certain findings on an echocardiogram. They should be taking steady heart failure medicines for at least 30 days. Their normal heart rate must also be lower than the personalized pacing rate that is based on their height and heart function.
What is Involved?
This study wants to find out if a pacemaker set to a heart rate that is personalized for each person can help people with HFpEF feel better and stay healthier. In HFpEF, the heart squeezes well but has trouble relaxing. The study will compare personalized pacing to very little pacing to see which helps more with symptoms, daily activities, and quality of life. The study will also check to make sure this treatment is safe for people with HFpEF.
Study Details
