Heart Failure Clinical Trial
Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).
Age >18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney.
Previous clinical diagnosis of HF with current NYHA Class II-III symptoms
At least one of the following: Hospitalization for decompensated HF, Acute treatment for HF with intravenous loop diuretic or hemofiltration, Chronic treatment with a loop diuretic for control of HF symptoms + left atrial enlargement on echocardiography or E/e' ratio (≥14 average, ≥15 septal ) on echocardiography, Resting PCWP >15 mm Hg or LV end-diastolic pressure >18 mmHg at catheterization for dyspnea and/or exercise PCWP/LV end-diastolic pressure >25 mmHg, or Elevated NT-proBNP level (≥300 pg/ml )
Left ventricular EF ≥40% within 12 months with clinical stability
Stable cardiac medical therapy for ≥30 days
Chronotropic incompetence on recent (within 6 months) clinical or screening exercise test, defined as heart rate reserve (HRR) <0.80 or <0.62 if on beta blockers
Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months.
Inability to exercise, or non-cardiac condition that precludes exercise testing
Any contraindication to a pacemaker system
Non-cardiac condition limiting life expectancy to less than one year
Significant left sided structural valve disease (>mild stenosis, >moderate regurgitation)
Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
Non-group 2 pulmonary arterial hypertension
Chronic stable exertional angina
Acute coronary syndrome or revascularization within 60 days
Other clinically important causes of dyspnea
PR interval >210 msec
Resting heart rate (HR) > 100 bpm
A history of reduced ejection fraction (EF<40%)
Advanced chronic kidney disease (GFR < 20 ml/min/1.73m2 by modified MDRD equation)
Women of child bearing potential without negative pregnancy test and effective contraception
Severe anemia (Hemoglobin <10 g/dL)
Severe hepatic disease
Complex congenital heart disease
Listed for cardiac transplantation
Other class I indications for pacing
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There is 1 Location for this study
Rochester Minnesota, 55905, United States
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