Pilot Study in Renal Denervation in Patients With Stroke and Uncontrolled Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 24 hour blood pressure
研究概览
简要总结
It is known, that hypertension is the major risk factor of stroke and recurrent stroke. Blood pressure reduction - together with antithrombotics - remain crucial in stroke prevention.
This pilot study will examine the effect of renal nerve denervation in patients with treatment resistant hypertension after ischemic stroke or DWI/DTI-verified stroke. With 24 hours blood pressure measurements the effect after renal nerve denervation is examined 1,3,6 and 12 months after the procedure.
详细描述
Radio frequent ablation is used to renal nerve denervation (RND) and is a new invasive method used in treatment for hypertensive patients, where the sympathetic nerves to the kidneys ablates. RND shows a significant reduction in the systolic and diastolic blood pressure in patients with treatment resistant hypertension.
The hypothesis is that RDN is able to reduce the blood pressure in patients with previous stroke and treatment resistant hypertension and thereby reduce the risk of a new stroke.
Aim of study:
- To validate the reduction in blood pressure after RND in patients with stroke and treatment resistant hypertension compared to the results achieved in patients only with essential hypertension
- To examine if this treatment is possible on patients after stroke (procedure related limitations and security of the patient)
- To describe the effect of RND in the development of changes in the white matter over time
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years old
- •Clinical verified stroke within the last year
- •Treatment resistant hypertension at 150 mm Hg or higher systolic at consultation
- •Modified Ranking between 0-2
排除标准
- •Lack of informed consent
- •Renal artery anatomy, which prevents the procedure
- •Reno vascular disease
- •Pacemaker
- •Haemodynamic vascular occlusion or valve disease
- •Pregnancy or women in the childbearing age
- •Secondary hypertension
- •Mean systolic blood pressure over 180 mm Hg
结局指标
主要结局
24 hour blood pressure
时间窗: 3 months
次要结局
未报告次要终点
研究者
Hanne Christensen
Associate Research Professor, Consultant neurologist
Bispebjerg Hospital