NCT01729988已完成不适用
Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study
Noblewell2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change of Blood Pressure
研究概览
简要总结
This is a pilot study to assess the effectiveness, safety and feasibility of carotid body removal in patients with high blood pressure (hypertension) resistant to medical treatment. Patients with high blood pressure are at significant risk of medical complications including stroke and heart disease. The principle research question is whether removal of the carotid body will lead to an improvement in the blood pressure of this patient group.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resistant HTN criteria with either confirmed sleep disordered breathing. Definition of HTN:Office SBP ≥ 160 mmHg and daytime mean ABPM ≥ 140 mm Hg
- •Definition of sleep disordered breathing: SDB defined as mild to moderate obstructive, central or mixed sleep apnea defined as 5 < AHI < 30 with O2 desaturation not exceeding 80% during the night.
排除标准
- •Calculated GFR < 30
- •Carotid body located outside the defined carotid septum
- •Obstructive carotid atherosclerotic disease
- •Oxygen desaturation at rest below 92%
- •Known structural lung disease (medical interview)
- •Requirement for oxygen therapy to maintain oxygen saturation
- •Patients wish to participate in mountain climbing, skin diving or free diving
- •Pregnancy or anticipation of pregnancy
- •Palliative care/chemotherapy
- •Acute coronary syndrome or unstable angina < 6 months prior to procedure
- •Use of exogenous insulin AND history of hypoglycemic unawareness
- •Stroke or transient ischaemic attack (TIA), or myocardial infarction < 6 months prior to procedure
- •Expected life expectancy less that 24months due to other disease
- •Intravenous drug use
- •Excessive use of alcohol or sedatives (Alcohol intake >28 units/week)
- •Obesity (BMI > 40)
- •Upper airway or facial abnormalities
- •Large neck circumference (>43.2 cm men; >40.6 cm women)
- •Febrile illness within two weeks of participation
- •Unable to attend for follow up appointments at 1, 3 and 6 months post operatively.
结局指标
主要结局
Change of Blood Pressure
时间窗: 3 months
Change from Baseline Blood Pressure at 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
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