Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 337
- 试验地点
- 109
- 主要终点
- Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
研究概览
简要总结
The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.
详细描述
The purpose of this study is to test the hypothesis that renal denervation is safe and reduces systolic blood pressure (SBP) in patients with uncontrolled hypertension on one, two, or three standard antihypertensive medications compared to a sham control in the same population. In this study, "uncontrolled hypertension" is defined as an office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg, an office Diastolic Blood Pressure (DBP) ≥90 mmHg and a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥140 mmHg to <170 mmHg, all of which are measured at Screening Visits. Data obtained will be used to confirm the effect of renal denervation on elevated blood pressure in patients on 1, 2 or 3 antihypertensive medications.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.
- •Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.
排除标准
- •Individual lacks appropriate renal artery anatomy.
- •Individual has estimated glomerular filtration rate (eGFR) of <
- •Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
- •Individual has one or more episodes of orthostatic hypotension.
- •Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
- •Individual has primary pulmonary hypertension.
- •Individual is pregnant, nursing or planning to become pregnant.
- •Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment
- •Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
- •Individual works night shifts.
研究组 & 干预措施
Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
干预措施: Symplicity Spyral™ multi-electrode renal denervation system (Device)
Sham Procedure
Renal angiography
干预措施: Sham Procedure (Procedure)
结局指标
主要结局
Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
时间窗: From baseline to 6 months post-procedure
Baseline adjusted change (using Analysis of Covariance) in systolic blood pressure (SBP) from baseline (Screening Visit 2) to 6 months post-procedure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
时间窗: From baseline to 1 month post-procedure (6 months for new renal artery stenosis)
The primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as a composite of the following events: All-cause mortality, End Stage Renal Disease (ESRD), Significant embolic event resulting in end-organ damage, Renal artery perforation requiring intervention, Renal artery dissection requiring intervention, Vascular complications, Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol, New renal artery stenosis \>70%, confirmed by angiography and as a determined by the angiographic core laboratory, through one-month post-randomization (6- months for new renal artery stenosis).
次要结局
- Antihypertensive Medication Burden to 6-months(From baseline to 6 Months post-procedure)
- Incidence of Achieving Target Office Systolic Blood Pressure(From baseline to 6 months post-procedure)
- Change in Office Systolic Blood Pressure(From baseline to 6 months post-procedure)
- Antihypertensive Medication Usage and Changes to 6-months(From baseline to 6-month post-procedure)
- Medication Changes(Baseline to 6-months post-procedure)