The Effect of Losartan on Atrial Fibrillation (AF) Burden and Pacemaker Dependence in Patients With Sick Sinus Syndrome
Recruitment status was Recruiting
This is a an investigator-initial, multicenter, open-label, randomized, parallel-group comparative study to evaluate the effect on the incidence of AF and pacemaker dependence in SSS patients receiving physiological atrial-based pacing alone or adding losartan 100mg to physiological atrial-based pacing treatment. The duration of the study will be approximately 13 months, comprising 4-week pre-study period, and 12-month treatment period.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||The Effect of Losartan on Atrial Fibrillation and Pacemaker Dependence in Sick Sinus Syndrome (SSS) Patients Receiving Physiological Pacemaker - A Prospective, Randomized, Multicenter Study in Taiwan|
- The proportion of patients who developed AF burden by pacemaker telemetry and developed permanent AF [ Time Frame: 12-month study period(2-week + 2-week + 4-week + 4-week + 3-month + 3-month + 3-month) ] [ Designated as safety issue: No ]
- The time to first occurrence of AF lasting for at least 1 minute after pacemaker insertion, and the AF burden over time measured as the portion of AF per day (in hours/day) [ Time Frame: 12-month study period(2-week + 2-week + 4-week + 4-week + 3-month + 3-month + 3-month) ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
Patients, aged 20 to 80 years, with SSS will be enrolled and randomly assigned to the Losartan 100mg add on physiological atrial-based pacing or physiological atrial-based pacing alone treatment arm.
|Placebo Comparator: B||
Patients, aged 20 to 80 years, with SSS will be enrolled and randomly assigned to the Placebo add on physiological atrial-based pacing or physiological atrial-based pacing alone treatment arm.
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|Contact: Kwo-Chang Ueng, MD; PhDfirstname.lastname@example.org; email@example.com|
|Chung Shan Medical University Hospital||Recruiting|
|Taichung, Taiwan, 402|
|Contact: Kwo-Chang Ueng, MD; PhD 886-4-24739595 ext 38231 firstname.lastname@example.org; email@example.com|
|Principal Investigator: Kwo-Chang Ueng, MD; PhD|
|Principal Investigator:||Kwo-Chang Ueng, MD; PhD||Chung Shan Medical University Hospital|