ELEVATE-HFpEF

Randomized trial of ELEVATEd cardiac pacing rate for personalized treatment of Heart Failure with preserved Ejection Fraction (ELEVATE-HFpEF).

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Heart failure
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Overview
Principal Investigator: Margaret Infeld

The study is a prospective, randomized, controlled, double-blinded, multicenter, global, interventional pivotal study evaluating the safety and efficacy of a personalized elevated cardiac pacing rate compared to minimal or no pacing for the treatment of patients with HFpEF. 

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Juan Carlos Collado Falcon

Study details
Inclusion Criteria
  • 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 NYHA ≥ II symptoms
  • 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/ml for patients with no AF or paroxysmal AF, or >900 pg/ml for patients with ≥persistent AF
    -Mean PCWP ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR PADP ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)
    -Echo criteria defined by >2 of:
    -LV wall thickness >12mm
    -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 e’ <7 cm/s or lateral e’ <10cm/s
    - TR velocity >2.8 m/s
    -LA enlargement, defined by LA volume index >34 ml/m2
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, ICD, CRT)
Study Requirements

Enrolled subjects will undergo a baseline assessment. Those with LVEF >50% on the baseline echocardiogram will be implanted with a Medtronic dual chamber transvenous pacemaker with a right ventricular lead placed in the conduction system. Following successful implant, and prior to hospital discharge, subjects will be randomized 1:1 to one of two study groups. In the first group, the subject’s pacemaker will be programmed to provide dual chamber pacing at a personalized rate determined by their LVEF and height, In the second group, the subject’s pacemaker will be programmed to provide ventricular pacing at a lower rate of 30 bpm. The estimated total study duration is approximately 4.5 years, representing an estimated 24-month enrollment period, 18-month follow-up period, and review by regulatory authorities. Echocardiogram and Blood draws will be completed at baseline, 6 month follow-up, 12 month follow-up and 18 month follow-up.