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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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).

Who is eligible to participate?

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 within 12 months before consent: 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 4. Left ventricular EF ≥50% 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 8. Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months. Peak VO2 ≤60% age/sex-adjusted normal value + peak respiratory exchange ratio (RER) ≥1.05 One of the following: NT-proBNP ≥400 pg/mL or NT-proBNP <400 pg/mL, with rest PCWP >20 mmHg and/or >25 mmHg with exercise 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<50%) 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

Last updated:

5/20/2014

NCT ID:

NCT02145351

IRB Number:

13-008306