Renal Denervation in Treatment Resistant Hypertension
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ClinicalTrials.gov Identifier: NCT01687725 |
Recruitment Status
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Recruiting
First Posted
: September 19, 2012
Last Update Posted
: January 12, 2018
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Tracking Information | |||||
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First Submitted Date | September 13, 2012 | ||||
First Posted Date | September 19, 2012 | ||||
Last Update Posted Date | January 12, 2018 | ||||
Study Start Date | November 2010 | ||||
Estimated Primary Completion Date | June 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | Complete list of historical versions of study NCT01687725 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Outcome Measures | Not Provided | ||||
Original Other Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Renal Denervation in Treatment Resistant Hypertension | ||||
Official Title | Renal Denervation in Treatment Resistant Hypertension | ||||
Brief Summary | 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 |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | treatment resistant hypertensive adults | ||||
Condition | Hypertension | ||||
Intervention | Device: Renal denervation using Symplicity Catheter system
percutaneous selective renal sympathetic nerve ablation with the use of the Symplicity Catheter system |
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Study Groups/Cohorts | Renal denervation
Renal denervation using Symplicity Catheter system
Intervention: Device: Renal denervation using Symplicity Catheter system |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
100 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 2018 | ||||
Estimated Primary Completion Date | June 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 85 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Germany | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT01687725 | ||||
Other Study ID Numbers | RD-TRH | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | University of Erlangen-Nürnberg Medical School | ||||
Study Sponsor | University of Erlangen-Nürnberg Medical School | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University of Erlangen-Nürnberg Medical School | ||||
Verification Date | January 2018 |