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:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01579058
Eligibility Criteria:
Inclusion Criteria:
* Mild to moderate aortic stenosis defined by peak velocity of aortic jet between 2.0 and 3.5 m/sec
* Untreated hypertension: systolic BP ≥ 140 or diastolic BP ≥ 90 mmHg Treated hypertension using dihydropiridine calcium channel blockers, ACE inhibitors, ARB or diuretics
* Patients received no beta-blocker therapy for more than 12 months
Exclusion Criteria:
* Symtomatic aortic stenosis: presence of exertional dyspnea, angina or syncope
* Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within the study period
* Stroke or resuscitated sudden death in the past 6 months
* Evidence of congestive heart failure, or left ventricular ejection fraction \< 50%
* Significant renal disease manifested by serum creatinine \> 2.0mg/dL
* History of intolerance to beta-blocker
* History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s)
* Moderate or severe aortic regurgitation
* Atrial fibrillation
* Female of child-bearing potential who do not use adequate contraception and women who are pregnant or breast-feeding
* A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer
* Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
* Unwillingness or inability to comply with the procedures described in this protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01579058
Study Brief:
Protocol Section:
NCT01579058