Published: May 12, 2026
Norton Heart & Vascular Institute continues to expand its role in advancing cardiovascular clinical research, joining a global clinical trial that potentially could redefine treatment for one of heart failure’s most challenging patient populations: heart failure with preserved ejection fraction, or HFpEF.
HFpEF patients retain normal left ventricular pumping function (LVEF ≥50%) but experience the full symptom burden of heart failure: dyspnea on exertion, fatigue, reduced exercise tolerance and recurrent hospitalizations.Despite recent pharmacologic advances, many patients decline symptomatically, even on optimized guideline-directed medical therapy, and device-based options are essentially nonexistent.
ELEVATE-HFpEF is a global, randomized, double-blinded, controlled clinical trial evaluating whether dual-chamber personalized pacing improves outcomes in patients with HFpEF, compared with minimal or no pacing for HFpEF patients.
According to Kent E. Morris, M.D., MBA, electrophysiologist with Norton Heart & Vascular Institute, the study aims to determine whether programming a pacemaker to a personalized pacing algorithm/rate, based on a patient’s left ventricular ejection fraction (LVEF) and height, improves symptoms, health status and other signs of HFpEF compared with standard minimal or nonpersonalized pacing.
All enrolled participants with symptomatic HFpEF receive a Medtronic dual-chamber pacemaker. Following successful implant and prior to discharge, subjects are randomized into one of two groups:
The trial will evaluate changes in symptoms, health status and other signs of HFpEF. The total study duration is approximately 4.5 years, including 24 months of enrollment and 18 months of follow-up.Study visits occur at two, six and 12 months. At 12 months, control group participants are switched to personalized pacing. Additional visits are scheduled at 14, 18 and 24 months. After 24 months, annual follow-up continues until study completion.
The ELEVATE-HFpEF trial is notable due to the patient population it targets: those without a traditional indication for a pacemaker.“This would be a new indication for pacing,” Dr. Morris said. “Currently there are no device or pacing indications for the HFpEF patient population.”
If the study meets its end points, personalized pacing could become the first device-based therapy available for HFpEF. For this population, medical management alone is often insufficient.
Norton Heart & Vascular Institute is the only site in Kentucky and one of just 18 in the U.S. (34 globally) participating in ELEVATE-HFpEF. According to Dr. Morris, the Louisville, Kentucky, institute owes its selection to its high volumes of heart failure patients and the strength of its device program.“Our volume of heart failure patients is one of the highest in the region and even the country, and our robust device clinic performs a high number of device implants,” he said. “If bringing this therapy to this patient population is beneficial, we are well positioned to help many of them.”
Dr. Morris serves as principal site investigator, with Megan E. Gruber, D.O., as subinvestigator.
For physicians managing symptomatic HFpEF patients, ELEVATE-HFpEF offers a new option to discuss with eligible candidates and a chance to help shape the evidence base for HFpEF care.
According to Dr. Morris, referrals will require careful consideration and robust patient education.“This is a device [pacemaker] implant in a patient that doesn’t have a traditional indication,” he said. “Instead, it is to treat their heart failure, which would be a new indication.”
A referral to Norton Heart & Vascular Institute clinical trials allows eligible patients to meet with the study team, review the trial and decide whether participation is right for them.Providers should review complete eligibility criteria and study details. To refer a patient to Norton Heart & Vascular Institute clinical trials and research, visit NortonEpicCareLink.comand open an order for Clinical Trial.