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.
Who Can Participate?
Eligibility
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.
Age Range
40-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Other
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Randomized trial of ELEVATEd cardiac pacing rate for personalized treatment of Heart Failure with preserved Ejection Fraction (ELEVATE-HFpEF)
Principal Investigator
Daniel
Friedman
Protocol Number
PRO00118389
NCT ID
NCT06678841
Phase
III
Enrollment Status
Pending Open to Enrollment