NCT01745172已完成不适用
Carotid Body Removal for the Treatment of Chronic Diseases Characterized by Excessive Central Sympathetic Activity Including Resistant Hypertension: a Pilot Study.
Noblewell2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2013年1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
- 4
- 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
- •Age of participants will be 18-75 years
- •Resistant HTN criteria:
- •Daytime mean ambulatory systolic blood pressure ≥135mmHg and office systolic blood pressure ≥150mmHg
- •Patients on at least three anti-hypertensive medications, including a diuretic, at maximum tolerated dose
- •No evidence of causes for secondary HTN following thorough clinical assessment
- •Patient medication concordance will be monitored via medication/blood pressure diary
排除标准
- •Calculated GFR <45ml/min/1.73m2
- •Carotid body located outside the defined carotid septum
- •Obstructive carotid atherosclerotic disease with >50% stenosis
- •Oxygen desaturation at rest below 92%
- •Known structural lung disease
- •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
- •Stroke or transient ischaemic attack (TIA) < 6 months prior to procedure
- •Expected life expectancy less than 12 months due to other disease
- •Intravenous drug use
- •Alcohol intake >28 units/week
- •Febrile illness within two weeks of participation
- •Unable to attend for follow up appointments in Bristol at 1, 3, 6, 12 and 24 months post-operatively.
- •MR imaging related exclusion criteria (all participants):
- •Pace-maker, implantable cardiac defibrillator, cerebral metallic clips or other implanted metal devices/structures
- •Unable to tolerate scanner or history of panic attacks/claustrophobia
- •Learning disability, significant hearing or visual impairment (participant would need to able to communicate from within the MRI scanner)
结局指标
主要结局
Change of Blood Pressure
时间窗: Baseline and 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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