Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, chronotropic incompetence
Eligibility Criteria
Inclusion Criteria:
- Age>18
- Congestive Heart Failure (CHF) (>6 months duration)
- Left Ventricular Ejection Fraction (LVEF) <40%
- Functional Class II-III
- Stable oral treatment (>1 month),
- Implanted Medtronic pacemaker/defibrillator with a) an atrial pacing lead and biventricular leads, or b) an atrial pacing lead and a single ventricular lead in patients with a narrow (normal) QRS complex (<120 msec) thus with no clinical indication for biventricular pacing.
- Low heart rate (HR) (sinus rhythm (SR) or atrial pacing <70 bpm)
- Symptomatically stable (with no clinical requirement for adjustments in medical therapy, i.e. diuretics)
- Increase in intrathoracic fluid as evidenced by rain natriuretic peptide (BNP) >200.
Exclusion criteria:
- Atrial fibrillation
- Stable or unstable angina
- Myocardial infarction within 6 months before the study
- Intravenous inotropic support
- Pregnant or breast feeding women. Women of child bearing potential must have a negative serum pregnancy test prior to enrollment.
- Severe renal failure (creatinine> 2.5 mg/dl, hemodyalisis or peritoneal dialysis)
- Known hepatic impairment (total bilirubin >3 mg/dL, albumin <2.8 mg/dL, or increased ammonia levels if performed)
- Hemoglobin (hgb) <8 mg %, or active bleeding requiring transfusion
Sites / Locations
- Columbia University
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Intervention first, then control
Control first, then intervention
Intervention Only
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers. On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour. On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter.
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers. On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour. On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter.
Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers. Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.