Renal Denervation in Treatment Resistant Hypertension | NCT01687725

NCT01687725

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

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

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Renal denervation		Renal denervation using Symplicity Catheter system	Device: Renal denervation using Symplicity Catheter system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renal denervation using Symplicity Catheter system	Device	percutaneous selective renal sympathetic nerve ablation with the use of the Symplicity Catheter system	Renal denervation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
office BP	change in office blood pressure from baseline to 6 months post-renal denervation	baseline, 6 months
24-ABPM	change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal denervation	baseline, 6 months
Magnetic resonance imaging (MRI)	change in total sodium content measured by MRI from baseline to 6 months post-renal denervation change in renal perfusion measured by MRI from baseline to 3 months post-renal denervation	baseline, 3 and 6 months
Albuminuria	change in urinary albumin/creatinine ratio from baseline to 6 months post-renal denervation	baseline, 6 months
Systemic RAS activity	change in sodium, potassium and creatinine from baseline to 6 months post-renal denervation change in aldosterone excretion from baseline to 6 months post-renal denervation change in sodium/potassium ratio from baseline to 6 months post-renal denervation change in plasma renin activity and angiotensin II concentration at least 30 minutes of rest in a supine position and immediately after standing from baseline to 6 months post-renal denervation	baseline, 6 months
Vascular structure and function of large and small arteries	change in flow-mediated vasodilation (FMD)from baseline to 6 months post-renal denervation change in scanning laser Doppler flowmetry (SLDF) from baseline to 6 months post-renal denervation change in funduscopy from baseline to 6 months post-renal denervation change in pulse wave analysis (PWA) from baseline to 6 months post-renal denervation change in pulse wave velocity (PWV) from baseline to 6 months post-renal denervation change in urinary albumine/creatinine ratio (UACR) of the morning spot urine sample from baseline to 6 months post-renal denervation

Secondary Outcomes

Measure	Description	Time Frame
BP	change in office BP from baseline to 3 and 12 months post-renal denervation change in 24 hour ABPM from baseline to 3 and 12 months post-renal denervation	3 and 12 months
MRI	change in total sodium content measured by MRI from baseline to 12 months post-renal denervation change in renal perfusion measured by MRI spin labelling technique from baseline to 1 day post-renal denervation

Eligibility Module

Name	Affiliation	Role
Roland E Schmieder, MD	University of Erlangen-Nürnberg	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg		Erlangen		91054	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25916737	Background	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.
27607458	Background	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases