NCT04307836招募中不适用
A Prospective, Multicenter, No-treatment Controlled, Randomized, Open-label, Pivotal Study to Evaluate the Safety and Efficacy of DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications
Kalos Medical34 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年7月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 34
- 主要终点
- Changes in average daytime ambulatory systolic blood pressure at 3 months
研究概览
简要总结
The objective of this study is to show that the safety and efficacy of renal denervation using DENEX, are superior to those of control group for the patients with hypertension on no or 1 to 3 antihypertensive medications.
详细描述
DENEX system developed by Handok Kalos Medical Inc. is a renal denervation system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged 19 to 75 years old
- •Subject should maintain the 0 to 3 antihypertensive medications of different classes, ACE-I, ARB, beta blocker, CCB or diuretics, without change for at least 4 weeks of run-in period between primary screening and secondary screening and for at least 3 months after the procedure
- •Subject with 140 mmHg ≤ average office SBP < 180 mmHg and 90 mmHg ≤ office DBP < 120 mmHg at primary and secondary screening
- •Subject with 135 mmHg ≤ average daytime ambulatory SBP <170 mmHg and 85 mmHg ≤ average daytime ambulatory DBP < 105 mmHg at secondary screening after the run-in period for at least 4 weeks
排除标准
- •Subject with the anatomical findings in kidney or renal artery which preclude renal denervation
- •Subject with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- •Subject with eGFR less than 40mL/min/1.73㎡
- •Subject with a brachial circumference greater than 42 cm.
- •Subject with secondary hypertension (except for sleep apnea patients)
- •Subject with a medical history of cerebrovascular disease or severe cardiovascular disease within 12 months prior to obtaining the consent or patients newly diagnosed with such diseases before enrollment.
- •Subject rehospitalized two or more times for hypertensive crisis within 12 months prior to obtaining consent or hospitalized for hypertensive crisis within three months prior to obtaining consent.
- •Subject with chronic oxygen therapy or mechanical ventilation (except for sleep apnea)
- •Subject with primary pulmonary hypertension
结局指标
主要结局
Changes in average daytime ambulatory systolic blood pressure at 3 months
时间窗: from baseline at 3 months after the procedure
Changes in average daytime ambulatory systolic blood pressure from baseline at 3 months after the procedure
次要结局
- Changes in average office systolic blood pressure and diastolic blood pressure at 1, 3, 6 and 12 months(from baseline at 1, 3, 6 and 12 months after the procedure)
- Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months(from baseline at 3, 6 and 12 months after the procedure)
- Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months(from baseline at 3, 6 and 12 months after the procedure)
研究者
研究点 (34)
Loading locations...
相似试验
招募中
不适用
DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive MedicationsVascular DiseasesCardiovascular DiseasesHypertensionNCT04535050Kalos Medical100
撤回
不适用
Renal Denervation in Patients With Chronic Heart FailureCardio-Renal SyndromeChronic Heart FailureNCT02085668University Hospital, Saarland
Unknown
不适用
Renal Denervation With Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary HypertensionPrimary HypertensionNCT03511313Synaptic Medical Corporation264
已完成
不适用
Impact of Sympathetic Renal Denervation- a Study in Patients After Renal TransplantationRenal TransplantationSympathetic ActivityChronic Kidney DiseaseHypertensionNCT01899456Technical University of Munich18
Unknown
1 期
Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic ActivityHeart Rhythm DisordersHypertensionHeart FailureDiabetesChronic Kidney DiseaseNCT01888315University Hospital, Saarland1,000