Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure (RAPID-HF)

Mayo Clinic

Status: Completed

Conditions: Heart Failure, Diastolic; Chronotropic Incompetence; Heart Failure With a Preserved Ejection Fraction

Treatments: Device: Rate adaptive atrial pacing using a dual-chamber pacemaker; Device: Pacemaker system will be implanted but set to Pacing Off.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02145351

13-008306

Details and patient eligibility

About

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).

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups

Pacing off first, then pacing on

Active Comparator group

Description:

No-pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing on for an additional 4 weeks.

Treatment:

Device: Pacemaker system will be implanted but set to Pacing Off.

Device: Rate adaptive atrial pacing using a dual-chamber pacemaker

Pacing on first, then pacing off

Experimental group

Description:

Pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing off for an additional 4 weeks

Treatment:

Device: Pacemaker system will be implanted but set to Pacing Off.

Device: Rate adaptive atrial pacing using a dual-chamber pacemaker