Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 试验地点
- 28
- 主要终点
- Change in OBP
研究概览
简要总结
To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.
详细描述
This study is a sham controlled, double blind study of subjects with uncontrolled hypertension consisting of two arms, sham and therapy. Bilateral renal denervation will be performed non-invasively using the Kona Medical Surround Sound System which delivers focused ultrasound therapy to ablate the nerves surrounding the renal artery utilizing real time ultrasound for targeting and tracking.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age and no more than 90 years of age
- •Average SBP ≥ 160 mmHg
- •24 hour average ABPM daytime SBP ≥ 135 mmHg.
- •No medication changes for a minimum of 1 months prior to screening.
- •At minimum, subject must be on at least three antihypertensive medications, with one being a diuretic, and each must meet one or more of the following full dose criteria:
- •Highest labeled dose according to medication's labeling;
- •Highest usual dose per clinical guidelines JNC-7;
- •Highest tolerated dose; and/or
- •Highest appropriate dose for the subject per the PI's clinical judgment.
- •Subject has two functioning kidneys.
- •Subject has an eGFR value of ≥ 30 ml/min/1.73 m² (MDRD formula).
排除标准
- •Subject has any secondary cause of hypertension
- •Subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and Doppler analysis on ultrasound
- •Subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
- •Subject has a history of intra-abdominal surgery within the past six months
- •Subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment.
- •Stenotic valvular heart disease for which BP reduction would be hazardous as determined by referring physician.
- •MI, unstable angina, or CVA in the prior 6 months.
- •Known severe primary pulmonary HTN
- •Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
- •Subject has hemodynamically significant valvular heart disease.
- •Subject has BMI over 40 km/m^2
- •Subject has a target treatment depth over 13 cm.
- •Subject has anatomy that precludes treatment with the Kona Medical Surround Sound System.
- •Subject is pregnant, nursing, or intends to become pregnant during the trial period.
- •Subject is currently enrolled in other potentially confounding research.
- •Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
- •Subject is unable, or unwilling, to comply with the protocol-required follow-up schedule
结局指标
主要结局
Change in OBP
时间窗: 6 months
Change in Office Systolic Blood Pressure (OBP) as measured from screening visit one to the 6 month post randomization follow-up visit.
Safety at 6 weeks follow-up
时间窗: 6 weeks
Safety will be assessed by incidence of Major Adverse Events (MAE), defined as a composite of the following events at 6-weeks follow-up. * All cause mortality; * End-stage Renal Disease defined as eGFR \< 15 ml/min or need for renal replacement therapy * Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications as assessed by toxicological and other medical analyses and testing. OR - New renal artery stenosis \> 70% confirmed by angiography within 6 months of randomization
次要结局
- Change in ABPM(6 months)