NCT01206439终止4 期
An Advanced Echocardiographic Evaluation of Nebivolol
Jack Rubinstein1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Systolic and Diastolic Myocardial Function
研究概览
简要总结
The purpose of this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance.
详细描述
Subjects will be given either 5 or 10 mg daily of oral Nebivolol for blood pressure control. They will undergo stress echocardiography at baseline, day 14, 90 and 180.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hypertension
- •Written informed consent before initiation of any study related procedure
- •Baseline Blood pressure > 140 systolic or >90 diastolic if on no antihypertensive therapy.
- •Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension.
排除标准
- •Physical limitations resulting in a limited ability to walk on treadmill for stress echo
- •Intolerance to beta blockers
- •On more than one medication for the treatment of hypertension unless the second medication is a diuretic.
- •Currently pregnant or breast feeding.
- •LFT > 3 X ULN
- •Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment
- •Unwilling to follow protocol or return for study related procedures.
- •Any of the following conditions:
- •Coronary artery disease Heart failure Valvular heart disease Ischemic heart disease Atrial fibrillation Pacemaker ICD Hyperlipidemia Diabetes Mellitus Stroke/TIA Anemia COPD Asthma Renal failure requiring dialysis Liver failure Cirrhosis Thyroid dysfunction
- •Any other medical condition that in the PI's opinion could affect myocardial function.
- •Current ETOH or illicit drug abuse -
研究组 & 干预措施
Nebivolol 5 or 10 mg, oral, daily
Experimental
Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.
干预措施: nebivolol (Drug)
结局指标
主要结局
Change in Systolic and Diastolic Myocardial Function
时间窗: Baseline to day 180
Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.
次要结局
- Exercise Tolerance(Baseline to day 180.)
研究者
Jack Rubinstein
Assistant Professor
University of Cincinnati
研究点 (1)
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