Status:
UNKNOWN
The Effect of Losartan on Atrial Fibrillation (AF) Burden and Pacemaker Dependence in Patients With Sick Sinus Syndrome
Lead Sponsor:
Chung Shan Medical University
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
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 receivin...
Detailed Description
Sick sinus syndrome is a common indication for permanent cardiac pacing in the community. It results from disordered impulse generation within the sinus node or impaired conduction of the impulse to t...
Eligibility Criteria
Inclusion
- Patient is willing to sign informed consent form.
- Men or women ≧ 20 and ≦ 80 years of age.
- Symptomatic bradycardia \< 40 beats/min or symptomatic QRS pauses of more than two seconds.
- Normal AV conduction (PQ interval ≦ 220 ms for patients≦ 70 years and a PQ interval ≦ 260 ms for patients \>70 years), and no bundle branch block (QRS width \< 120 ms)
Exclusion
- Patient has history of known intolerance, contraindication or hypersensitivity to losartan.
- 1st, 2nd or 3rd AV block
- Permanent or therapy refractory AF
- Blood pressure \> 250/120 mmHg at visit 1.
- Heart Failure acc. NYHA III or IV
- Myocardial infarction less than 6 months before pacemaker implant (visit 1)
- Cerebral disease or stroke less than 6 months before pacemaker implant (visit 1)
- Hypertrophic obstructive cardiomyopathy
- Symptomatic hypo- or hyperthyroidism
- Cardiogenic shock
- Women who are pregnant or lactating.
- Unstable angina pectoris
- Patients under 20 years of age
- Patients involved in other studies
- Systolic pressure \< 100 mmHg at the visit 1
- Reduced expectancy of life due to other diseases
- Patients who cannot attend follow-up visits regularly
- Patient has clinically important abnormal laboratory findings at the visit 1 local laboratory screen including: Serum creatinine \> 2.5 mg/dL; Serum potassium \< 3.5 or \> 5.7 eEq/L; SGOT/SGPT (ALT/AST) \> 3 times of the upper normal limits; Blood hemoglobin (males \& females \< 10 g/dL)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00647257
Start Date
April 1 2008
End Date
December 1 2009
Last Update
April 1 2010
Active Locations (1)
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1
Chung Shan Medical University Hospital
Taichung, Taiwan, 402