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临床试验 NCT05590871 针对高血压目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension
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临床试验NCT05590871是一项针对高血压的干预性研究试验，目前试验状态为招募中。试验始于2023年3月31日，计划招募180名患者。该研究由Shanghai Hongdian Medical CO., LTD主导，预计于2026年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年11月20日。
简要概括
To verify the safety and effectiveness of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the renal denervation of essential hypertension.
详细描述
This trial is a prospective, multi-center, randomized controlled clinical study to verify the safety and efficacy of the renal artery radiofrequency ablation system under the guidance of the three-dimensional cardiac electrophysiological mapping system in the application of renal denervation of essential hypertension，designed to include drug-control research and sham-control resarch. Provide the basis for product registration and marketing and clinical application. Drug-control research include 65 subiects (5 are subjects trained and taught by the experimental group leader unit center, 40 subjects are randomly to the renal artery ablation with durg treatment group, 20 subjects to the drug treatment group). Sham-control research include 180 subjects, will be randomly assigned according to 2:1 (120 subjects in the renal artery ablation with drug treatment group and 60 subjects in the sham procedure with drug treatment group).
Patients will be followed for blood pressure measurement and antihypertensive medication at 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, and 12 months after the procedure. Patients' urine samples will be collected for drug testing (LC-MS/MS) to determine their medication compliance in an independent laboratory.
官方标题
3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial
疾病
高血压其他研究标识符
- 714156A
NCT编号
实际开始日期
2023-03-31
最近更新发布
2024-11-20
预计完成日期
2026-12-31
计划入组人数
180
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Renal Denervation Percutaneous renal denervation using the FlashPoint radio-frequency ablation system under the Columbus 3D mapping system guidance | Flashpoint Renal Denervation System Radio-frequency ablation of renal arterial sympathetic nerves |
模拟对照sham For those subjects randomized to the sham procedure, renal artery angiography will serve as the sham procedure.
Subjects maintenance of anti-hypertensive medications. | 假 After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
24-hour ambulatory mean systolic blood pressure reduction | The primary effectiveness endpoint is change in 24-hour ambulatory mean systolic blood pressure from baseline to 6 months post-randomization | Baseline to 6 months |
The incidence of Major Adverse Events (MAE) | Safty outcome | Baseline to 1 month |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Reduction in office systolic and diastolic BP | Secondary outcome | Baseline to 1, 3, 6 months post procedure |
Reduction in average 24h ambulatory diastolic BP | Baseline to 1, 3, 6 months post procedure | |
Reduction in home systolic and diastolic BP | Baseline to 1, 2, 3, 4, 5, 6 months post procedure | |
Percentage of subjects change the number, class, dose of antihypertensive drugs | Baseline to 1, 2, 3, 4, 5, 6 months post procedure | |
Difference in antihypertensive drug burden index | Baseline to 6 months post procedure | |
Subjects level of TTR ( time in target BP range) | Baseline to 6 months post procedure | |
Success rate of the renal interventional therapy procedure | Procedure success rate defined as successful introduction of the catheter, navigation to the treatment site, and there are no procedure-related SAE. | during the procedure |
Incident of acute procedure safety events | 7 days post procedure | |
Incident of chronic procedure safety events | 6 months post procedure | |
Incidence of TTR with MAE, all cause death, stroke and myocardial infarction | Baseline to 6 months post procedure | |
Incidence of adverse events | Baseline to 6 months post procedure | |
Incident of serious adverse events | Baseline to 6 months post procedure | |
Ablation system defect rate | During procedure |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Males or females aged ≥18 and ≤70 (not pregnant, breastfeeding, and have no reproductive plan within one year);
- Patients with essential hypertension, antihypertensive drug intolerance, and willing to undergo surgical treatment;
- Ambulatory blood pressure measurement 24-hour average systolic blood pressure ≥130mmHg or daytime ≥135mmHg, and pulse pressure difference <80 mmHg;
- A history of using antihypertensive medication within six months and blood pressure is still uncontrollable; standardized medication (at least two drugs) for at least 28 days before enrollment, and medication compliance ≥ 80%, office systolic blood pressure (OSBP) ) ≥ 150 mmHg and <180 mmHg, diastolic blood pressure (DBP) ≥ 90 mmHg;
- The patients agree to participate in this clinical trial and sign the informed consent form, agreeing to follow-up evaluation under the requirements of the verification protocol.
Renal artery anatomy failures include:
- Renal artery diameter <4mm or treatment length <20mm;
- Renal artery stenosis >50% or renal aneurysm on either side;
- A history of renal artery intervention, including balloon angioplasty or stenting or RDN;
Glomerular filtration rate (eGFR) <45mL/min/1.73m2 (MDRD formula);
History of hospitalization for hypertensive crisis in the past year;
During the screening and lead-in period, the patient used antihypertensive drugs other than the standard antihypertensive drugs prescribed in this study protocol;
Nocturnal sleep apnea syndrome requires mechanical ventilation (such as tracheostomy);
Those who have or are currently suffering from the following diseases or conditions:
- Primary pulmonary hypertension (moderate to severe);
- Type I diabetes;
- History of any cerebrovascular events (eg, stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months;
- History of any serious cardiovascular event within 3 months (eg, myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV), unstable angina attack);
- Factors that interfere with blood pressure measurement in any case (eg, patients with severe peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, severe anemia);
- Arranged or planned surgery or cardiovascular intervention within the next 6 months;
- Patients with malignant tumors and end-stage diseases who survival period is less than 1year;
Patients with secondary hypertension.
Patients who are deemed inappropriate to participate in this trial by other investigators.
Shanghai Hongdian Medical CO., LTD研究中心联系人
联系人: Yuehui Yin, MD, +86 13508335502, [email protected]
联系人: Yingxian Sun, MD, +86 13804068889, [email protected]
27 位于 1 个国家/地区的研究中心
Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400037, China
招募中
Chongqing General Hospital, Chongqing, Chongqing Municipality, 401147, China
招募中
Fujian
Cardiovascular Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361016, China
招募中
Gansu
The Second Hospital of Lanzhou University, Lanzhou, Gansu, China
招募中
Guangdong
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China
尚未招募
Guizhou
Guizhou Provincial People's Hospital, Guiyang, Guizhou, 550002, China
招募中
Heilongjiang
First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China
招募中
Henan
The 7th People's Hospital of Zhengzhou, Zhengzhou, Henan, 450016, China
招募中
Zhengzhou Central Hospital, Zhenzhou, Henan, China
招募中
Jiangsu
Changzhou No.2 People's Hospital, Changzhou, Jiangsu, 213003, China
招募中
Liaoning
Ansteel Group General Hospital, Anshan, Liaoning, China
尚未招募
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116014, China
尚未招募
The First Hospital of China Medical University, Shengyang, Liaoning, 110001, China
招募中
The People's Hospital of Liaoning Province, Shenyang, Liaoning, 110017, China
招募中
Shandong
Weifang People's Hospital, Weifang, Shandong, China
招募中
Shanghai Municipality
Shanghai General Hospital, Shanghai, Shanghai Municipality, 201620, China
招募中
Shanxi
The Second Affiliated Hospital of Air Force Medical University of PLA, Xi’an, Shanxi, 710038, China
招募中
Sichuan
West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China
招募中
First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan, China
招募中
The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646099, China
招募中
Mianyang Central Hospital, Mianyang, Sichuan, 621000, China
招募中
Tianjin Municipality
Tianjin Chest Hospital, Tianjin, Tianjin Municipality, 300300, China
招募中
Tianjin First Central Hospital, Tianjin, Tianjin Municipality, 300384, China
招募中
Xinjiang
First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, China
尚未招募
Yunnan
Yan'an Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
招募中
Zhejiang
The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, 315016, China
招募中
Shenzhen Guangming District People's Hospital, Shenzhen, China
招募中