Renal Denervation in Treatment Resistant Hypertension
In patients with treatment resistant hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labeling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.
The investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation:
Short term effects:
A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the kidney C)Exaggerated sodium excretion immediately after renal nerve ablation
Long term effects:
D)Decrease of total sodium content after 6 and 12 months E)Improvement of vascular wall properties after 6 and 12 months
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Erlangen、德国、91054
- Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
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Homburg/Saar、德国、66421
- Klinik für Innere Medizin, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- treatment resistant hypertension
- male of female aged over 18 years
- written informed consent
- agreement to attend all study visits as planned in the protocol
Exclusion Criteria:
- chronic kidney disease 3 - 5
- any contradictions for MRI
- claustrophobia
- strabismus
- severe ocular diseases
- history of epilepsia
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Renal denervation
Renal denervation using Symplicity Catheter system
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percutaneous selective renal sympathetic nerve ablation with the use of the Symplicity Catheter system
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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 |
---|---|---|
office BP
大体时间:baseline, 6 months
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change in office blood pressure from baseline to 6 months post-renal denervation
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baseline, 6 months
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24-ABPM
大体时间:baseline, 6 months
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change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal denervation
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baseline, 6 months
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Magnetic resonance imaging (MRI)
大体时间:baseline, 3 and 6 months
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baseline, 3 and 6 months
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Albuminuria
大体时间:baseline, 6 months
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change in urinary albumin/creatinine ratio from baseline to 6 months post-renal denervation
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baseline, 6 months
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Systemic RAS activity
大体时间:baseline, 6 months
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baseline, 6 months
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Vascular structure and function of large and small arteries
大体时间:baseline, 6 months
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baseline, 6 months
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Local RAS activity
大体时间:baseline, 6 months
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change in urinary angiotensinogen concentration from the morning spot urine from baseline to 6 months post-renal denervation
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baseline, 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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BP
大体时间:3 and 12 months
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3 and 12 months
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MRI
大体时间:1 day and 12 months
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1 day and 12 months
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Local RAS activity
大体时间:1 day, 3 and 12 months
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change urinary angiotensinogen concentration from the morning spot urine from baseline to 1 day, 3 and 12 months post-renal denervation
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1 day, 3 and 12 months
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Systemic RAS activity
大体时间:1 day, 3 and 12 months
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1 day, 3 and 12 months
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Albuminuria
大体时间:3 and 12 months
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- change in albuminuria from baseline to 3 and 12 months post-renal denervation
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3 and 12 months
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Vascular structure and function of large and small arteries
大体时间:3 and 12 months
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3 and 12 months
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合作者和调查者
出版物和有用的链接
一般刊物
- Schmieder RE, Ott C, Schmid A, Friedrich S, Kistner I, Ditting T, Veelken R, Uder M, Toennes SW. Adherence to Antihypertensive Medication in Treatment-Resistant Hypertension Undergoing Renal Denervation. J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343.
- Ott C, Harazny JM, Schmid A, Ditting T, Veelken R, Bladowski M, Michelson G, Uder M, Schmieder RE. Retinal microperfusion after renal denervation in treatment-resistant hypertensive patients. Clin Res Cardiol. 2015 Sep;104(9):782-9. doi: 10.1007/s00392-015-0845-0. Epub 2015 Apr 28.
- Ott C, Mahfoud F, Schmid A, Ewen S, Toennes SW, Meyer MR, Helfer AG, Maurer HH, Ditting T, Veelken R, Zivanovic I, Uder M, Bohm M, Schmieder RE. The effect of renal denervation in moderate treatment-resistant hypertension with confirmed medication adherence. J Hypertens. 2016 Dec;34(12):2475-2479. doi: 10.1097/HJH.0000000000001110.
- Ott C, Mahfoud F, Schmid A, Toennes SW, Ewen S, Ditting T, Veelken R, Ukena C, Uder M, Bohm M, Schmieder RE. Renal denervation preserves renal function in patients with chronic kidney disease and resistant hypertension. J Hypertens. 2015 Jun;33(6):1261-6. doi: 10.1097/HJH.0000000000000556.
- Bosch A, Schmid A, Ott C, Kannenkeril D, Karg MV, Ditting T, Veelken R, Uder M, Schmieder RE. Copeptin Levels in Patients With Treatment-Resistant Hypertension Before and 6 Months After Renal Denervation. Am J Hypertens. 2020 Feb 22;33(2):182-189. doi: 10.1093/ajh/hpz155.
- Ott C, Kopp C, Dahlmann A, Schmid A, Linz P, Cavallaro A, Hammon M, Ditting T, Veelken R, Uder M, Titze J, Schmieder RE. Impact of renal denervation on tissue Na+ content in treatment-resistant hypertension. Clin Res Cardiol. 2018 Jan;107(1):42-48. doi: 10.1007/s00392-017-1156-4. Epub 2017 Aug 28.
- Ott C, Schmid A, Toennes SW, Ditting T, Veelken R, Uder M, Schmieder RE. Central pulse pressure predicts BP reduction after renal denervation in patients with treatment-resistant hypertension. EuroIntervention. 2015 May;11(1):110-6. doi: 10.4244/EIJV11I1A19.
- Ott C, Mahfoud F, Schmid A, Ditting T, Veelken R, Ewen S, Ukena C, Uder M, Bohm M, Schmieder RE. Improvement of albuminuria after renal denervation. Int J Cardiol. 2014 May 1;173(2):311-5. doi: 10.1016/j.ijcard.2014.03.017. Epub 2014 Mar 15.
- Ott C, Mahfoud F, Schmid A, Ditting T, Sobotka PA, Veelken R, Spies A, Ukena C, Laufs U, Uder M, Bohm M, Schmieder RE. Renal denervation in moderate treatment-resistant hypertension. J Am Coll Cardiol. 2013 Nov 12;62(20):1880-6. doi: 10.1016/j.jacc.2013.06.023. Epub 2013 Jul 10.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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