The Effect of Losartan on Atrial Fibrillation (AF) Burden and Pacemaker Dependence in Patients With Sick Sinus Syndrome

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chung Shan Medical University
• Treatments: Losartan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)