Sympathetic Nervous System Modulation in Hypertension by Beta-adrenergic Blockade
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 24
- 主要终点
- Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio
研究概览
简要总结
This is a study of patients with high blood pressure who are already treated with an angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic nervous system, thereby further improving left ventricular filling and blood pressure control.
详细描述
Patients were to receive sympathetic cardiac innervation testing with I-123 MIBG at baseline and again after receiving a titrate dose of beta-blocker. Data were to be assesses by repeated measures testing.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor or angiotensin receptor blocker
排除标准
- •Known valvular heart disease of more than mild severity
- •Known coronary artery disease defined by an angiographic coronary artery stenosis greater than or equal to 50% luminal diameter narrowing, acute or previous myocardial infarction, or previous coronary revascularization
- •Known non-ischemic cardiomyopathy with left ventricular ejection fraction less than 50%
- •Atrial fibrillation
- •Current treatment with a β-adrenergic blocking drug or a calcium channel blocker
- •Current treatment with a psychoactive or other drug known to alter 123I-MIBG uptake
- •Participation in another research study within the prior 30 days
- •A life-limiting disease process that is likely to preclude completion of study participation
- •Pregnancy or breast feeding
- •Inability or unwillingness to provide informed consent
- •Baseline resting heart rate less than 65 beats per minute
- •Iodine allergy
- •Unwilling to sign informed consent.
研究组 & 干预措施
metoprolol succinate
Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.
干预措施: Metoprolol Succinate (Drug)
结局指标
主要结局
Improvement in Sympathetic Cardiac Innervation as Measured by I-123 MIBG Heart - Mediastinum Ratio
时间窗: january 2018
24 subjects had baseline I-123 MIBG imaging. No subject completed all aspects of the protocol. The study was closed due to unfavorable publication related to metoprolol treatment for hypertension.
次要结局
未报告次要终点
研究者
Myron C. Gerson
Professor
University of Cincinnati