Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT00647257
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT00647257
Study Brief:
Protocol Section:
NCT00647257