SPYRAL HTN-ON MED 研究
2026年6月9日 更新者：Medtronic Vascular
使用 Symplicity Spyral™ 多电极肾脏去神经系统对接受标准药物治疗的未控制高血压患者进行肾脏去神经支配的全球临床研究 (SPYRAL HTN-ON MED)
本研究的目的是检验肾去神经支配降低血压的假设，并且在存在多达三种标准抗高血压药物的情况下进行研究时是安全的。
研究概览
详细说明
本研究的目的是检验以下假设：与同一人群中的假手术对照相比，对于使用一种、两种或三种标准抗高血压药物但未得到控制的高血压患者，肾去神经术是安全的，并且可以降低收缩压 (SBP)。
在本研究中，“未控制的高血压”被定义为诊室收缩压（SBP）≥150mmHg且<180mmHg、诊室舒张压（DBP）≥90mmHg以及24小时动态血压监测（ABPM）平均 SBP ≥140 mmHg 至 <170 mmHg，所有这些值均在筛选访视时测量。
获得的数据将用于确认去肾神经术对服用 1、2 或 3 种抗高血压药物的患者血压升高的影响。
研究类型
介入性
注册 (实际的)
337
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Hamilton、Ontario、加拿大
- Hamilton Heath
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Toronto、Ontario、加拿大
- St. Michael's Hospital
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Wels、奥地利、4600
- Klinikum Wels-Grieskirchen
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Athens、希腊、11527
- Hippokration General Hospital of Athens
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Thessaloniki、希腊、54621
- University General Hospital of Thessaloniki (AHEPA)
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Bad Krozingen、德国、79189
- Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
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Erlangen、德国、91054
- Universitätsklinikum Erlangen
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Homburg、德国、66421
- Universitatsklinikum des Saarlandes
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Leipzig、德国、04289
- Herzzentrum Leipzig, Universitätsklinik
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Lübeck、德国、23560
- Sana Kliniken Lubeck
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Osaka、日本
- Saiseikai Nakatsu Hospital
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Hyōgo
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Takarazuka、Hyōgo、日本
- Higashi Takarazuka Satoh Hospital
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Okamoto
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Kamakura、Okamoto、日本
- Shonan Kamakura General Hospital
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Tochigi
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Shimotsuke、Tochigi、日本、329-0498
- Jichi Medical University Hospital
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Tokyo
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Chiyoda City、Tokyo、日本、101-8643
- Mitsui Memorial Hospital
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Toulouse、法国
- Clinique Pasteur
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Kogarah、澳大利亚
- St. George Hospital
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Perth、澳大利亚
- Royal Perth
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Victoria
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Melbourne、Victoria、澳大利亚、3004
- Alfred Hospital
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Galway、爱尔兰
- Galway University Hospital
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Alabama
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Huntsville、Alabama、美国、35801
- Heart Center Research, LLC
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California
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Stanford、California、美国、94305
- Stanford Hospital and Clinics
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Connecticut
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New Haven、Connecticut、美国、06520
- Yale New Haven Hospital
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District of Columbia
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Washington D.C.、District of Columbia、美国、20422
- Washington DC VA Medical Center
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Florida
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Jacksonville、Florida、美国、32207
- Baptist Medical Center Jacksonville
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Jacksonville、Florida、美国、32216
- Memorial Hospital Jacksonville
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Tallahassee、Florida、美国、32308
- Tallahassee Research Institute
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Georgia
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Atlanta、Georgia、美国、30308
- Emory University Hospital Midtown
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Atlanta、Georgia、美国、30309
- Piedmont Heart Institute
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Iowa
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West Des Moines、Iowa、美国、50266
- Iowa Heart Center
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Kentucky
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Lexington、Kentucky、美国、40536
- University of Kentucky
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Michigan
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Pontiac、Michigan、美国、48341
- St Joseph Mercy Oakland
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Southfield、Michigan、美国、48075
- Providence Hospital
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Minnesota
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Minneapolis、Minnesota、美国、55407
- Minneapolis Heart Institute Foundation
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Mississippi
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Hattiesburg、Mississippi、美国、39401
- Hattiesburg Clinic
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Tupelo、Mississippi、美国、38801
- Cardiology Associates Research LLC
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Missouri
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St Louis、Missouri、美国、63110
- Barnes-Jewish Hospital
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New Jersey
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Livingston、New Jersey、美国、07039
- Saint Barnabas Medical Center
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New York
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Manhasset、New York、美国、11030
- North Shore University Hospital
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New York、New York、美国、10029
- Mount Sinai Medical Center
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New York、New York、美国、10021
- Weill Cornell Medical College/The New York Presbyterian Hospital
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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Ohio
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Cleveland、Ohio、美国、44106
- University Hospitals Cleveland Medical Center
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health & Science University Hospital
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Pennsylvania
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Harrisburg、Pennsylvania、美国、17011
- PinnacleHealth Cardiovascular Institute
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Philadelphia、Pennsylvania、美国、19104
- Hospital of the University of Pennsylvania
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Rhode Island
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Providence、Rhode Island、美国、02906
- The Miriam Hospital
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South Carolina
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Anderson、South Carolina、美国、29621
- AnMed Health
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Tennessee
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Nashville、Tennessee、美国、37203
- Centennial Medical Center
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Texas
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Dallas、Texas、美国、75226
- Baylor Heart & Vascular Hospital
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West Virginia
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Charleston、West Virginia、美国、25304
- Charleston Area Medical Center
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Wisconsin
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Milwaukee、Wisconsin、美国、53215
- Aurora St. Luke's Medical Center
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Bournemouth、英国
- Royal Bournemouth Hospital
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Cardiff、英国
- Cardiff and Vale University Health Board - University Hospital of Wales
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Exeter、英国、EX2 5DW
- Royal Devon & Exeter NHS Foundation Trust
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London、英国、W12 0HS
- Imperial College Healthcare NHS Trust
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 80年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 个人办公室收缩压 (SBP) ≥ 150 mmHg 并且
- 个体的 24 小时动态血压监测 (ABPM) 平均 SBP ≥ 140 mmHg 且 < 170 mmHg。
排除标准：
- 个体缺乏适当的肾动脉解剖结构。
- 个人估计肾小球滤过率 (eGFR) 为
- 个人患有 1 型糖尿病或控制不佳的 2 型糖尿病。
- 个体有一次或多次直立性低血压发作。
- 除了睡眠呼吸暂停的夜间呼吸支持外，个人需要长期氧气支持或机械通气。
- 个体患有原发性肺动脉高压。
- 个人怀孕、哺乳或计划怀孕。
- 个人经常间歇性或慢性疼痛，导致在入组前一个月内每周使用非甾体类抗炎药 (NSAID) 治疗两天或更多天
- 个体入组3个月内有稳定型或不稳定型心绞痛，入组3个月内有心肌梗死；随时发生心力衰竭、脑血管意外或短暂性脑缺血发作、心房颤动。
- 个人工作夜班。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：去肾神经
肾血管造影和肾去神经支配（Symplicity Spyral™ 多电极肾去神经支配系统）
|
根据标准程序进行肾血管造影后，受试者仍处于盲态状态，并在随机化后立即接受肾去神经术治疗。
其他名称：
|
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假比较器：假手术
肾血管造影
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根据标准程序进行肾血管造影后，受试者保持盲态并在导引鞘移除之前在导管插入实验室桌上停留至少 20 分钟。
其他名称：
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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 |
|---|---|---|
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通过 24 小时动态血压监测 (ABPM) 测量的收缩压变化
大体时间：从基线到术后 6 个月
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通过 24 小时动态血压监测 (ABPM) 测量，收缩压 (SBP) 从基线（筛选访视 2）到术后 6 个月的基线调整变化（使用协方差分析）。
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从基线到术后 6 个月
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Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
大体时间：From Baseline to 1 month post-procedure (6 months for new renal artery stenosis)
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The Primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as 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 determined by the angiographic core laboratory, through one-month post-randomization (6-months for new renal artery stenosis)
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From Baseline to 1 month post-procedure (6 months for new renal artery stenosis)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
6个月内抗高血压药物的使用和变化
大体时间：从基线到术后 6 个月
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从基线（筛选访视 2）到术后 6 个月的药物数量
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从基线到术后 6 个月
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6个月内的抗高血压药物负担
大体时间：从基线到术后 6 个月
|
根据报告的处方药物，使用药物指数 2 评分计算药物负担，该评分是基于抗高血压药物剂量乘以处方药物数量的综合指数；所有类别（ACE/ARB、钙通道阻滞剂等）均被认为具有同等效力。 分数越高表明处方剂量高于标准剂量。 最小值0；无最大值 |
从基线到术后 6 个月
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药物变化
大体时间：术后 6 个月的基线
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根据药物指数 2 药物检测数据进行药物改变的患者。
药物指数2评分是基于抗高血压药物剂量乘以处方药物数量的综合指数；所有类别（ACE/ARB、钙通道阻滞剂等）均被认为具有同等效力。
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术后 6 个月的基线
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达到目标办公室收缩压的发生率
大体时间：从基线到术后 6 个月
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术后 6 个月达到办公室收缩压目标 (SBP<140 mmHg) 的发生率。
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从基线到术后 6 个月
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Change in Office Systolic Blood Pressure to 6-months
大体时间：From baseline to 6 months post-procedure
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Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure
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From baseline to 6 months post-procedure
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Change in Systolic Blood Pressure as Measured by 24-hour ABPM 12 Months
大体时间：From Baseline to 12 months post procedure
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Change in systolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
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From Baseline to 12 months post procedure
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Change in Systolic Blood Pressure as Measured by 24-hour ABPM 24-months
大体时间：From baseline to 24 months post-procedure
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Change in systolic blood pressure from baseline (screening visit 2) to 24 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From baseline to 24 months post-procedure
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Change in Systolic Blood Pressure as Measured by 24-hour ABPM 36-months
大体时间：From baseline to 36 months post-procedure
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Change in systolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From baseline to 36 months post-procedure
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Change in Office Systolic Blood Pressure to 12-months
大体时间：From Baseline to 12 months post procedure
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Change in office systolic blood pressure from baseline (screening visit 2) to 12 months.
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From Baseline to 12 months post procedure
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Change in Office Systolic Blood Pressure to 24-months
大体时间：From baseline to 24 months post-procedure
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Change in office systolic blood pressure from baseline (screening visit 2) to 24 months.
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From baseline to 24 months post-procedure
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Change in Office Systolic Blood Pressure to 36-months
大体时间：From baseline to 36 months post-procedure
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Change in office systolic blood pressure from baseline (screening visit 2) to 36 months.
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From baseline to 36 months post-procedure
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Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 12-months
大体时间：From Baseline to 12 months post procedure
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Change in diastolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From Baseline to 12 months post procedure
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Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 24-months
大体时间：From baseline to 24 months post-procedure
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Change in diastolic blood pressure from baseline (screening visit 2) to 24 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From baseline to 24 months post-procedure
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Change in Diastolic Blood Pressure as Measured by 24-hour ABPM 36-months
大体时间：From baseline to 36 months post-procedure
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Change in diastolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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From baseline to 36 months post-procedure
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Change in Office Diastolic Blood Pressure 12 Months
大体时间：From baseline to 12 months post-procedure
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Change in office diastolic blood pressure from baseline (screening visit 2) to 12 months.
|
From baseline to 12 months post-procedure
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Change in Office Diastolic Blood Pressure 24 Months
大体时间：From baseline to 24 months post-procedure
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Change in office diastolic blood pressure from baseline (screening visit 2) to 24 months.
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From baseline to 24 months post-procedure
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Change in Office Diastolic Blood Pressure 36 Months
大体时间：From baseline to 36 months post-procedure
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Change in office diastolic blood pressure from baseline (screening visit 2) to 36 months.
|
From baseline to 36 months post-procedure
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Number of Participants Achieving Target Office Systolic Blood Pressure 12 Months
大体时间：From baseline to 12 months post-procedure
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Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
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From baseline to 12 months post-procedure
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Number of Participants Achieving Target Office Systolic Blood Pressure 24 Months
大体时间：From baseline to 24 months post-procedure
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Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg).
|
From baseline to 24 months post-procedure
|
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Number of Participants Achieving Target Office Systolic Blood Pressure. 36 Months
大体时间：From baseline to 36 months post-procedure
|
Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
|
From baseline to 36 months post-procedure
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|
Number of Participants With All Cause Mortality
大体时间：From Baseline to 36-months post procedure
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From Baseline to 36-months post procedure
|
|
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Number of Participants With End-Stage Renal Disease (ESRD)
大体时间：From Baseline to 36-months post-procedure
|
End-stage Renal Disease (ESRD) - defined as two or more eGFR measurements <15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:
|
From Baseline to 36-months post-procedure
|
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Number of Participants With Significant Embolic Event Resulting in End-organ Damage
大体时间：From Baseline to 36 months post-procedure
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From Baseline to 36 months post-procedure
|
|
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Number of Participants With Renal Artery Perforation Requiring Intervention
大体时间：From Baseline to 36 month post-procedure
|
Renal artery perforation requiring intervention
|
From Baseline to 36 month post-procedure
|
|
Number of Participants With Renal Artery Dissection Requiring Intervention
大体时间：From Baseline to 36 months post-procedure
|
Number of Participants with Renal artery dissection requiring intervention
|
From Baseline to 36 months post-procedure
|
|
Number of Participants With Vascular Complications
大体时间：From Baseline to 36 months post-procedure
|
Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).
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From Baseline to 36 months post-procedure
|
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Number of Participants With Hospitalization for Hypertensive Crisis Not Related to Confirmed Non-adherence With Medications and/or the Protocol.
大体时间：From Baseline to 36 months post-procedure
|
From Baseline to 36 months post-procedure
|
|
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Number of Participants With New Renal Artery Stenosis > 70%, Confirmed by Angiography and as Determined by the Angiographic Core Laboratory
大体时间：From Baseline to 36 months post-procedure
|
From Baseline to 36 months post-procedure
|
|
|
Number of Participants With ≥ 40% Decline in eGFR
大体时间：From baseline to 36 months post-procedure
|
From baseline to 36 months post-procedure
|
|
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Number of Participants With Increase in Serum Creatinine >50% From Screening Visit 2 (Baseline)
大体时间：From baseline to 36 months post-procedure
|
From baseline to 36 months post-procedure
|
|
|
Number of Participants With New Myocardial Infarct
大体时间：From baseline to 36 months post-procedure
|
From baseline to 36 months post-procedure
|
|
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Number of Participants With New Stroke
大体时间：From baseline to 36 months post-procedure
|
From baseline to 36 months post-procedure
|
|
|
Number of Participants With Renal Artery Re-intervention
大体时间：From baseline to 36 months post-procedure
|
From baseline to 36 months post-procedure
|
|
|
Number of Participants With Major Bleeding According to TIMI Definition
大体时间：From baseline to 36 months post-procedure
|
Major bleeding according to TIMI definition (i.e.
intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure
|
From baseline to 36 months post-procedure
|
|
Change in Diastolic Blood Pressure as Measured by 24-hour (ABPM) 6-months
大体时间：From baseline to 6 months post-procedure
|
Change in diastolic blood pressure from baseline (screening visit 2) to 6 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
|
From baseline to 6 months post-procedure
|
|
Change in Office Diastolic Blood Pressure to 6-months
大体时间：From baseline to 6 months post-procedure
|
Change in office diastolic blood pressure from baseline (screening visit 2) to 6 months post-procedure
|
From baseline to 6 months post-procedure
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Antihypertensive Medication Burden to 36-months
大体时间：From baseline to 36 months post-procedure
|
Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose. There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison) |
From baseline to 36 months post-procedure
|
|
Antihypertensive Medication Burden to 24-months
大体时间：From baseline to 24 months post-procedure
|
Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose. There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison) |
From baseline to 24 months post-procedure
|
|
Antihypertensive Medication Burden to 12-Months
大体时间：From Baseline to 12 months post-procedure
|
Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose. There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison) |
From Baseline to 12 months post-procedure
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Raymond Townsend, MD、University of Pennsylvania
- 首席研究员：David Kandzari, MD、Piedmont Hospital
- 首席研究员：Michael Böhm, MD、Universitätskliniken des Saarlandes
- 首席研究员：Kazuomi Kario, MD、Jichi Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mahfoud F, Kandzari DE, Kario K, Townsend RR, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Dimitriadis K, Choi JW, East C, D'Souza R, Sharp ASP, Ewen S, Walton A, Hopper I, Brar S, McKenna P, Fahy M, Bohm M. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. Lancet. 2022 Apr 9;399(10333):1401-1410. doi: 10.1016/S0140-6736(22)00455-X. Epub 2022 Apr 4.
- Kandzari DE, Hickey GL, Pocock SJ, Weber MA, Bohm M, Cohen SA, Fahy M, Lamberti G, Mahfoud F. Prioritised endpoints for device-based hypertension trials: the win ratio methodology. EuroIntervention. 2021 Apr 2;16(18):e1496-e1502. doi: 10.4244/EIJ-D-20-01090.
- Kario K, Weber MA, Bohm M, Townsend RR, Mahfoud F, Schmieder RE, Tsioufis K, Cohen SA, Fahy M, Kandzari DE. Effect of renal denervation in attenuating the stress of morning surge in blood pressure: post-hoc analysis from the SPYRAL HTN-ON MED trial. Clin Res Cardiol. 2021 May;110(5):725-731. doi: 10.1007/s00392-020-01718-6. Epub 2020 Aug 1.
- Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.
- Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Bohm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11.
- Bohm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7.
- Kandzari DE, Mahfoud F, Townsend RR, Kario K, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Liu M, DeBruin V, Brar S, Bohm M. Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial. Circ Cardiovasc Interv. 2025 Jul;18(7):e015194. doi: 10.1161/CIRCINTERVENTIONS.125.015194. Epub 2025 May 20.
- Townsend RR, Ferdinand KC, Kandzari DE, Kario K, Mahfoud F, Weber MA, Schmieder RE, Pocock S, Tsioufis K, David S, Steigerwalt S, Walton A, Hopper I, Bertolet B, Sharif F, Fengler K, Fahy M, Hettrick DA, Brar S, Bohm M. Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED. Hypertension. 2024 May;81(5):1095-1105. doi: 10.1161/HYPERTENSIONAHA.123.22251. Epub 2024 Feb 5.
- Kandzari DE, Townsend RR, Kario K, Mahfoud F, Weber MA, Schmieder RE, Pocock S, Tsioufis K, Konstantinidis D, Choi J, East C, Lauder L, Cohen DL, Kobayashi T, Schmid A, Lee DP, Ma A, Weil J, Agdirlioglu T, Schlaich MP, Shetty S, Devireddy CM, Lea J, Aoki J, Sharp ASP, Anderson R, Fahy M, DeBruin V, Brar S, Bohm M; SPYRAL HTN-ON MED Investigators. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. 2023 Nov 7;82(19):1809-1823. doi: 10.1016/j.jacc.2023.08.045.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年7月22日
初级完成 (实际的)
2022年8月18日
研究完成 (实际的)
2025年8月14日
研究注册日期
首次提交
2015年4月28日
首先提交符合 QC 标准的
2015年5月6日
首次发布 (估计的)
2015年5月12日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月9日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.