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ELEVATE-HFpEF Clinical Study
NCT06678841 · Medtronic Cardiac Rhythm and Heart Failure
In plain English
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Official title
Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)
About this study
This study will evaluate a personalized cardiac pacing rate as a treatment for symptomatic heart failure with preserved ejection fraction (LVEF ≥50%). The intervention is designed to improve health status and other signs and symptoms of heart failure in patients with HFpEF. After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. Following successful implant, and prior to pre-hospital discharge, subjects will be randomized 1:1 to one of two study groups. In the first group, subjects will have their pacemaker programmed to dual chamber pacing at a personalized cardiac pacing rate (treatment group) based on their LVEF and height. Subjects randomized to the second group will have their pacemaker programmed to receive ventricular pacing at a non-personalized rate to minimize interference with the subject's intrinsic heart rate (control group).
Subjects will complete 2-month, 6-month, and 12-month visits where data will be collected. At the 12-month visit, the second group (control group) will also be programmed to their personalized cardiac pacing rate. Subjects will complete 14-month, 18-month, and 24-month visits where data will be collected. Following the 24-month visit, additional long-term follow-up visits will occur annually until study completion. The estimated study duration is approximately 4.5 years representing an estimated 24-month enrollment period and 18-month follow-up period.
Eligibility criteria
Inclusion Criteria:
1. Age ≥ 40 years
2. Documented EF ≥50% within the preceding 12 months
3. HFpEF defined as:
1. Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR
2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:
* Interstitial / pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure
* Elevated NT-proBNP in the last year defined as \>400 pg/m for patients with no AF or paroxysmal AF, or \>900 pg/ml for patients with ≥persistent AF
* Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)
* Echo criteria defined by ≥2 of:
* LV wall thickness ≥ 12 mm
* LV mass index (BSA indexed LVH): sex at birth male \>115 g/m2, sex at birth female \>95 g/m2
* Relative wall thickness ≥0.42
* E/e' ≥15 in sinus rhythm (or \> 11 in the setting of atrial fibrillation) OR septal \<7 cm/s or lateral e' \<10cm/s
* Tricuspid regurgitation (TR) velocity \>2.8 m/s
* Left atrial (LA) enlargement, defined by LA volume index \>34 ml/m2
4. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days
5. Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible)
6. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).
Exclusion Criteria:
1. Improved or recovered EF (i.e., prior LVEF\<50%)
2. Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT))
3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
4. Average heart rate \<50 bpm or symptomatic bradycardia
5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit.
6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
7. Severe obesity defined as BMI \>45.
8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \<50 bpm or evidence of ventricular pauses exceeding 6 seconds
9. Planned AF ablation
10. Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)
11. Hypertrophic cardiomyopathies
12. Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart
13. End Stage Renal Disease (CKD 4 or greater)
14. More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)
15. Significant primary pulmonary disease on home oxygen
16. Known contraindication for a pacemaker implant
17. Advanced co-morbidity with life expectancy \< 1 year
18. Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager.
19. Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).
Study design
Enrollment target: 700 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-07-09
Estimated completion: 2029-02
Last updated: 2026-06-01
Interventions
Device: Personalized cardiac pacing
Primary outcomes
- • Primary Efficacy Objective: Hierarchical composite endpoint of cardiovascular mortality, urgent HF events, HF events requiring an oral diuretic intensification (ODI), change in KCCQ, change in six-minute walk test distance, and change in NT-proBNP. (Follow-up duration for endpoint analysis is 12-months.)
- • Primary Safety Objective: Percentage of patients with major complications related to the system or procedure. (12-months post pacemaker implant attempt.)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure · industry
Contacts & investigators
ContactDawn Dyer · contact · dawn.dyer@medtronic.com · 954-682-8334
All locations (44)
Banner - University Medical Center PhoenixRecruiting
Phoenix, Arizona, United States
Sutter Health HospitalRecruiting
San Francisco, California, United States
Hartford HospitalRecruiting
Hartford, Connecticut, United States
Cardiovascular Institute of Northwest FloridaRecruiting
Panama City, Florida, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
The University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Norton HealthcareRecruiting
Louisville, Kentucky, United States
Cardiovascular Institute of the SouthRecruiting
Houma, Louisiana, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
M Health Fairview University of Minnesota Medical Center - East BankRecruiting
Minneapolis, Minnesota, United States
Saint Lukes Mid America Heart InstituteRecruiting
Kansas City, Missouri, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
The Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States
Mount Carmel EastRecruiting
Columbus, Ohio, United States
Lancaster General HospitalRecruiting
Lancaster, Pennsylvania, United States
Lankenau Institute for Medical ResearchRecruiting
Wynnewood, Pennsylvania, United States
Medical University of South Carolina (MUSC)Recruiting
Charleston, South Carolina, United States
Saint Thomas Research InstituteRecruiting
Nashville, Tennessee, United States
Dallas VA Medical CenterRecruiting
Dallas, Texas, United States
Texas Health Research & Education InstituteRecruiting
Fort Worth, Texas, United States
The University of Vermont Medical CenterRecruiting
Burlington, Vermont, United States
Inova Fairfax HospitalRecruiting
Falls Church, Virginia, United States
Saint Joseph Medical Center (Tacoma WA)Recruiting
Tacoma, Washington, United States
Charleston Area Medical Center (CAMC) Memorial HospitalRecruiting
Charleston, West Virginia, United States
Froedtert HospitalRecruiting
Milwaukee, Wisconsin, United States
The Prince Charles HospitalRecruiting
Chermside, Queensland, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Ordensklinikum Linz GmbH / ElisabethinenRecruiting
Linz, Austria
Universitair Ziekenhuis AntwerpenRecruiting
Edegem, Belgium
Saint Pauls HospitalRecruiting
Vancouver, Canada
Fakultni nemocnice Královské VinohradyRecruiting
Prague, Czechia
Centre Hospitalier Universitaire Besancon - Hôpital Jean MinjozRecruiting
Besançon, France
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-MontpiedRecruiting
Clermont-Ferrand, France
CHU Toulouse - Hôpital RangueilRecruiting
Toulouse, France
Prince of Wales HospitalRecruiting
Hong Kong, Hong Kong
Queen Elizabeth Hospital (Hong Kong)Recruiting
Hong Kong, Hong Kong
Kokura Memorial HospitalRecruiting
Kitakyushu, Fukuoka, Japan
Sarawak Heart CentreRecruiting
Kota Samarahan, Malaysia
Institut Jantung Negara - National Heart InstituteRecruiting
Kuala Lumpur, Malaysia
Oslo Universitetssykehus-RikshospitaletRecruiting
Oslo, Norway
University Medical Centre LjubljanaRecruiting
Ljubljana, Slovenia
Hôpitaux Universitaires de GenèveRecruiting
Geneva, Switzerland
The Leeds Teaching Hospitals NHS Trust - Leeds General InfirmaryRecruiting
Leeds, United Kingdom
Manchester University NHS Foundation Trust - Manchester Royal InfirmaryRecruiting
Manchester, United Kingdom