Feasibility Study of Perivascular Computer Tomography-guided Ethanol Sympatholysis for the Treatment of Therapy-resistant Arterial Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Success or failure of the peri-arterial technique injection of ethanol under CT guidance.
研究概览
简要总结
In this study the investigators are going to assess the feasibility of this innovate technique of renal sympathetic denervation by translumbar access under ct-guidance.
To limit the potential impact on the kidney, the investigators chose a population of chronic renal failure patients on dialysis or renal transplant (with native kidneys still present) and having resistant treatment hypertension despite antihypertensive combination therapy well conducted.
The investigators expect to obtain a decrease of the blood pressure at the 24-hours ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more or equal than 18 years old,
- •patient with triple antihypertensive therapy (maximum tolerated dose) with a diuretic, except for anuric patients, and without modification treatment:
- •in the last two months,
- •expected in the next three months,
- •renal transplanted patients with native kidneys followed for hypertension before transplant, and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation OR
- •chronic renal failure patient with dialysis and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation
- •patient affiliated to social security or similarly regime
- •patient who signed the consent to participate in the study
- •No Inclusion Criteria:
- •renal artery anatomy against-indicating the procedure including:
- •3 homolateral renal arteries
- •kidney surgery including bypass surgery or renal artery reimplantation
- •volume-dependent type of hypertension
- •secondary hypertension (not included nephropathy)
- •orthostatic hypotension associated with symptoms during the previous year
- •medical history including:
- •acute coronary syndrome, unstable angina, stroke within 6 months preceding the period of inclusion,
- •surgery scheduled on the kidney, the renal arteries or the retroperitoneum during patient participation in the study period
- •chronic alcoholism
- •anticoagulants or antiplatelet agents for which a therapeutic window can not be considered (except aspirin dose less than or equal to 160mg / day)
- •contraindication to the realization of an MRI
- •included in another trial assessing a medicament or a medical device or a surgical procedure
- •protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
排除标准
- 未提供
研究组 & 干预措施
Renal sympathicolysis
The patient will have:
- Ambulatory Blood Pressure Monitoring
- Magnetic Resonance Angiography
- Blood test
- Renal sympathicolysis
- Ambulatory Blood Pressure Monitoring
- Magnetic Resonance Angiography
干预措施: Renal sympathicolysis (Procedure)
Renal sympathicolysis
The patient will have:
- Ambulatory Blood Pressure Monitoring
- Magnetic Resonance Angiography
- Blood test
- Renal sympathicolysis
- Ambulatory Blood Pressure Monitoring
- Magnetic Resonance Angiography
干预措施: Ambulatory Blood Pressure Monitoring (Procedure)
Renal sympathicolysis
The patient will have:
- Ambulatory Blood Pressure Monitoring
- Magnetic Resonance Angiography
- Blood test
- Renal sympathicolysis
- Ambulatory Blood Pressure Monitoring
- Magnetic Resonance Angiography
干预措施: Magnetic Resonance Angiography (Radiation)
Renal sympathicolysis
The patient will have:
- Ambulatory Blood Pressure Monitoring
- Magnetic Resonance Angiography
- Blood test
- Renal sympathicolysis
- Ambulatory Blood Pressure Monitoring
- Magnetic Resonance Angiography
干预措施: Blood test (Biological)
结局指标
主要结局
Success or failure of the peri-arterial technique injection of ethanol under CT guidance.
时间窗: 2 hours
Assess the technical feasibility of a new procedure of renal denervation chemical sympatholysis with ethanol, by a translumbar access, guided by CT, in a population of chronic dialysis or transplant failure patients followed for resistant treatment hypertension. The measure is a score based on the distribution of the ethanol near the aorta-renal angle
次要结局
- Change of the blood pressure between baseline and 1 month after surgery The results of this difference is in mmHg.(baseline at one month before surgery and 1 month after surgery)
- Any clinical adverse event, radiological or biological related to the procedure and between it and the end of the study (MRI and follow up to 1 month).(One month)
- Duration of the procedure between the first scanner acquisition and the latest acquisition of control. The result is in minutes.(2 hours)
- A score will be established with one point by angle aorto-renal upper cover and one point on each quarter of the circumference of renal artery covered with ethanol.(One month)