Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure

Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)

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).

Inclusion Criteria

1. Age >18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney.
2. Previous clinical diagnosis of HF with current NYHA Class II-III symptoms
3. 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 )
4. Left ventricular EF ≥40% within 12 months with clinical stability
5. Stable cardiac medical therapy for ≥30 days
6. Sinus rhythm
7. 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
8. Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months.

Exclusion Criteria

1. Inability to exercise, or non-cardiac condition that precludes exercise testing
2. Any contraindication to a pacemaker system
3. Non-cardiac condition limiting life expectancy to less than one year
4. Significant left sided structural valve disease (>mild stenosis, >moderate regurgitation)
5. Hypertrophic cardiomyopathy
6. Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
7. Pericardial disease
8. Non-group 2 pulmonary arterial hypertension
9. Chronic stable exertional angina
10. Acute coronary syndrome or revascularization within 60 days
11. Other clinically important causes of dyspnea
12. Atrial fibrillation
13. PR interval >210 msec
14. Resting heart rate (HR) > 100 bpm
15. A history of reduced ejection fraction (EF<40%)
16. Advanced chronic kidney disease (GFR < 20 ml/min/1.73m2 by modified MDRD equation)
17. Women of child bearing potential without negative pregnancy test and effective contraception
18. Severe anemia (Hemoglobin <10 g/dL)
19. Severe hepatic disease
20. Complex congenital heart disease
21. Listed for cardiac transplantation
22. Other class I indications for pacing