ELEVATE-HFpEF Clinical Study (NCT06678841) | Clinical Trial Compass
RecruitingNot Applicable
ELEVATE-HFpEF Clinical Study
United States700 participantsStarted 2025-07-09
Plain-language summary
ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Age ≥ 40 years
✓. Documented EF ≥50% within the preceding 12 months
✓. HFpEF defined as:
✓. 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
✓. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:
✓. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days
✓. 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)
✓. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).
Exclusion criteria
✕. Improved or recovered EF (i.e., prior LVEF\<50%)
✕. 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))
What they're measuring
1
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.
Timeframe: Follow-up duration for endpoint analysis is 12-months.
2
Primary Safety Objective: Percentage of patients with major complications related to the system or procedure.
Timeframe: 12-months post pacemaker implant attempt.
. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
✕. Average heart rate \<50 bpm or symptomatic bradycardia
✕. 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.
✕. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \<50 bpm or evidence of ventricular pauses exceeding 6 seconds