Atrial Fibrillation Rate Control Therapy Guided By Continuous Ambulatory Monitoring
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Atrial Fibrillation Rate Control Therapy Guided By Continuous Ambulatory Monitoring|
- Time to adequate heart rate (HR) control, defined as resting heart rate ≤ 80 bpm and average heart rate over 24 hours < 100 and no recorded HR > 110% of maximum age-adjusted predicted HR.
- Total health care costs associated with conventional and Cardionet based monitoring strategy.
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||September 2006|
|Estimated Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
This is an open, randomized controlled trial to compare a standard rate-control strategy with one using the Cardionet device to guide therapy for the management of atrial fibrillation. Patients presenting to an outpatient clinic or to the Emergency Department with atrial fibrillation with a ventricular rate greater than 100 bpm at rest will be enrolled.
Patients will be prescribed either a beta blocker or a calcium channel blocker, or have their baseline dose increased if already taking one of these agents at the discretion of the treating physician. This is consistent with standard outpatient treatment guidelines for rate control in atrial fibrillation.
At the time of enrollment, patients will be randomized to a standard rate control protocol or a rate-control protocol guided by the Cardionet device.
Standard Care (Comparison Group):
Patients randomized to standard care will have a home patient educator install the Cardionet device within 24 hours after enrollment. The Cardionet device will be used to adjudicate the primary endpoint of adequate rate control in the standard care group. The patient's treating physician will be blinded to the reports from the Cardionet device. These patients will have another office visit with the initial referring physician or a staff cardiologist within the first week after enrollment and weekly thereafter. At this time, adequacy of rate control will be assessed by a standard 12-lead electrocardiogram and patient history. Medication will be adjusted per protocol. The patient will be seen on a weekly basis until adequate rate control is thought to have been achieved.
Rate Control using Cardionet (Study Group):
Patients randomized to use of the Cardionet device will have a home patient educator install the device within 24 hours after enrollment. Electrocardiographic summaries will be reviewed by a research physician three times a week and treatment decisions will be made based on a summary of 24-hour rate control. The physician will contact the patient by telephone and make medication adjustments per protocol. Three-times-weekly transmissions and medication adjustments will continue until adequate rate control is achieved over a period of 24 hours.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115843
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Peter Zimetbaum, MD||Beth Israel Deaconess Medical Center|