超声神经消融导管与超声神经消融装置一起用于治疗药物不耐受患者的难治性高血压或高血压的有效性和安全性 (ModulationHTN2)
一项前瞻性,多中心,随机,对照临床试验,可评估超声肾脏去神经导管的有效性和安全性,并结合超声肾脏去神经修饰装置,用于治疗难治性高血压或药物不耐受性高血压
Prospective, multicenter, randomized, controlled, blinded, and superiority - designed; The target population undergoes a screening treatment with prescribed medications for at least 4 weeks. Eligible subjects are randomly assigned to the experimental group and the control group at a ratio of 2:1. The experimental group is treated with the ultrasound nerve ablation catheter and the ultrasound nerve ablation device of Shenzhen Maiwei Medical Technology Co., Ltd., while the control group only undergoes renal arteriography (regarded as a sham operation). Within 6 months after the operation, both groups continue to receive antihypertensive drug treatment with the dosage and types specified during the screening period. The subjects are kept blinded during the study. The relative change values of the average 24 - hour ambulatory systolic blood pressure from the baseline at 6 months after the operation are compared between the two groups.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Guangzhou、中国
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age between 18 and 70 years old (calculated based on the date of starting standardized medication).
- After treatment with at least two types of antihypertensive drugs for 4 weeks or more, the clinic systolic blood pressure is ≥140 mmHg and ≤180 mmHg, and the average 24 - hour ambulatory systolic blood pressure is ≥130 mmHg (or the daytime ambulatory systolic blood pressure is ≥135 mmHg).
- Resting heart rate ≥70 beats per minute without taking beta - blockers (this criterion does not apply to patients taking beta - blockers).
- The subject agrees to participate in this clinical trial, complies with the follow - up required by the trial protocol, and has voluntarily signed the informed consent form
Exclusion Criteria:
- CTA, MRA, or DSA examination shows that the shape and structure of the unilateral or bilateral renal arteries are not suitable for ablation surgery (renal artery stenosis exceeding 50%, renal artery aneurysm, fibromuscular dysplasia of the renal artery, or the diameter of the main renal artery is less than 3 mm).
- Having only one kidney or having received a kidney transplant.
- Having a history of renal artery interventional treatment or renal denervation surgery.
- Suffering from any condition that may affect the accuracy of blood pressure measurement, such as the upper arm diameter being too large relative to the cuff.
- Secondary hypertension (excluding apnea syndrome).
- Glomerular filtration rate (eGFR) < 45 mL/min/1.73m² (MDRD formula).
- Having a history of hospitalization due to hypertensive crisis within one year before randomization for enrollment.
- Suffering from type 1 diabetes.
- Suffering from primary pulmonary hypertension.
- Being allergic to contrast agents.
- Severe cardiac valve stenosis.
- Cardiac insufficiency (NYHA class III - IV).
- Hyperthyroidism or hypothyroidism.
- Requiring mechanical ventilation for assisted breathing (except for nocturnal respiratory support for treating sleep apnea).
- Acute or severe systemic infection.
- Having an implantable cardioverter - defibrillator (ICD) or pacemaker.
- Having obvious symptoms of active peptic ulcer (such as abdominal pain, nausea, vomiting, regurgitation, etc.).
- Having obvious bleeding tendency and hematological diseases.
- Having a history of surgery or trauma requiring hospitalization within 30 days before randomization for enrollment.
- Having a cardiovascular event (stable or unstable angina, myocardial infarction) or cerebrovascular event (stroke, cerebrovascular accident, transient ischemic attack) within 6 months before randomization for enrollment.
- Pregnant, lactating women, or women planning to become pregnant during the study period.
- Currently participating in other clinical trials of drugs or medical devices.
- Other reasons that the investigator deems inappropriate for participation in this study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:超声肾脏神经
|
Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device |
|
假比较器:肾动脉造影
|
Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The average change value of 24 - hour ambulatory systolic blood pressure (ASBP) relative to the baseline
大体时间:Six months after surgery
|
The average change value of 24 - hour ambulatory systolic blood pressure (ASBP) relative to the baseline at 6 months after surgery |
Six months after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The change values of clinic systolic blood pressure and diastolic blood pressure relative to the baseline
大体时间:3 months and 6 months after surgery
|
The changes in clinic systolic and diastolic blood pressures relative to the baseline at 3 months and 6 months after surgery |
3 months and 6 months after surgery
|
|
The attainment rate of clinic diastolic blood pressure
大体时间:3 months and 6 months after surgery
|
The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery |
3 months and 6 months after surgery
|
|
The average change value of 24 - hour ambulatory diastolic blood pressure relative to the baseline
大体时间:3 months and 6 months after surgery
|
The average change values of 24 - hour ambulatory diastolic blood pressure relative to the baseline at 3 months and 6 months after surgery |
3 months and 6 months after surgery
|
|
The average change value of 24 - hour ambulatory systolic blood pressure relative to the baseline
大体时间:Three months after surgery
|
The average change value of 24 - hour ambulatory systolic blood pressure relative to the baseline at 3 months after surgery |
Three months after surgery
|
|
The proportion of patients with a reduction in clinic systolic blood pressure of ≥5 mmHg, 10 mmHg, 15 mmHg, and 20 mmHg
大体时间:3 months and 6 months after surgery
|
The proportion of patients with a reduction in clinic systolic blood pressure of ≥ 5 mmHg, 10 mmHg, 15 mmHg, and 20 mmHg at 3 months and 6 months after surgery |
3 months and 6 months after surgery
|
|
Changes in the drug composite index of the types and dosages of antihypertensive medications
大体时间:Six months after surgery
|
Changes in the drug composite index of the types and dosages of antihypertensive drugs 6 months after surgery |
Six months after surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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