Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate
Stopped early · Not applicable
Conditions studied: Heart Failure
In brief
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 body retains. We hypothesize that we can provide assistance to their body in mobilizing this fluid by artificially increasing their heart rate using a pacemaker. We plan to conduct a prospective clinical trial to evaluate this hypothesis. We will use a cross over design to study patients who already have biventricular pacemakers implanted or a narrow QRS and volume overload. We will screen them using a blood test that is a rough estimate of volume overload. Patients who meet the inclusion criteria will be randomly assigned to have their pacemakers adjusted or to have no intervention during the first of 2 visits. They will be unaware of which group they are in. Following adjustment, they will be monitored for six hours. Prior to the pacemaker adjustment, several tests will be performed to evaluate heart function and the levels of hormones related that are affected by heart failure. These tests will be repeated at the end of the six hour intervention period in each visit. At the end of the visit patients who had their pacemakers adjusted will have it reset to their original settings.
Key facts
- Study ID
- NCT00698139
- Run by
- Columbia University
- People needed
- 3
- Starts
- 2011-04-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2018-04-27
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.