Status:
TERMINATED
Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Many patients with heart failure are unable to increase their heart rate appropriately when their body needs increased blood flow. As a result, they may be unable to mobilize excess fluid that their b...
Detailed Description
Many patients with heart failure suffer from chronotropic incompetence, an inability to raise their heart rate in response to metabolic demand. Previous studies have shown that brief increases in paci...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00698139
Start Date
April 1 2011
End Date
September 1 2012
Last Update
April 27 2018
Active Locations (1)
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1
Columbia University
New York, New York, United States, 10032