Clinical trial NCT02145351: Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Official title: Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With a Preserved Ejection Fraction
Heart Failure, Diastolic
Chronotropic Incompetence
Keywords: HFpEF
Heart failure
Heart failure with preserved ejection fraction
Chronotropic incompetence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2014-05-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT)
timeFrame: baseline, after 4 weeks of treatment
Secondary outcomes:
measure: Peak Aerobic Capacity (Peak VO2)
timeFrame: 4 weeks after pacemaker activation
measure: Ventilatory Efficiency (VE/VCO2)
timeFrame: 4 weeks
measure: Change in Plasma N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
timeFrame: baseline, after 4 weeks of treatment
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
timeFrame: baseline, after 4 weeks of treatment
Other outcomes:
measure: Mean Peak Heart Rate (HR)
timeFrame: 4 weeks
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barry Borlaug, MD
role: PRINCIPAL_INVESTIGATOR
References: