Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Renal Denervation in Treatment Resistant Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01687725
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Tracking Information
First Submitted Date September 13, 2012
First Posted Date September 19, 2012
Last Update Posted Date February 18, 2020
Actual Study Start Date November 2010
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2012)
  • office BP [ Time Frame: baseline, 6 months ]
    change in office blood pressure from baseline to 6 months post-renal denervation
  • 24-ABPM [ Time Frame: baseline, 6 months ]
    change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal denervation
  • Magnetic resonance imaging (MRI) [ Time Frame: baseline, 3 and 6 months ]
    • 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
  • Albuminuria [ Time Frame: baseline, 6 months ]
    change in urinary albumin/creatinine ratio from baseline to 6 months post-renal denervation
  • Systemic RAS activity [ Time Frame: baseline, 6 months ]
    • 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
  • Vascular structure and function of large and small arteries [ Time Frame: baseline, 6 months ]
    • 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
  • Local RAS activity [ Time Frame: baseline, 6 months ]
    change in urinary angiotensinogen concentration from the morning spot urine from baseline to 6 months post-renal denervation
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 18, 2012)
  • BP [ Time Frame: 3 and 12 months ]
    • 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
  • MRI [ Time Frame: 1 day and 12 months ]
    • 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
  • Local RAS activity [ Time Frame: 1 day, 3 and 12 months ]
    change urinary angiotensinogen concentration from the morning spot urine from baseline to 1 day, 3 and 12 months post-renal denervation
  • Systemic RAS activity [ Time Frame: 1 day, 3 and 12 months ]
    • change in sodium potassium and creatinine from baseline to 1 day, 3 and 12 months post-renal denervation
    • change in aldosterone excretion from baseline to 1 day, 3 and 12 months post-renal denervation
    • change in sodium/potassium ratio from baseline to 1 day, 3 and 12 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 1 day, 3 and 12 months post-renal denervation
  • Albuminuria [ Time Frame: 3 and 12 months ]
    - change in albuminuria from baseline to 3 and 12 months post-renal denervation
  • Vascular structure and function of large and small arteries [ Time Frame: 3 and 12 months ]
    • change in flow mediated vasodilation (FMD) from baseline to 12 months post-renal denervation
    • change in scanning laser Doppler flowmetry (SLDF) from baseline to 12 months post-renal denervation
    • change in funduscopy from baseline to 3 and 12 months post-renal denervation
    • change in pulse wave analysis (PWA) from baseline to 12 months post-renal denervation
    • change in pulse wave velocity (PWV) from baseline to 12 months post-renal denervation
    • change in urinary albumine/creatinine ratio of the morning spot urine sample from baseline to 3 and 12 months post-renal denervation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
Study Groups/Cohorts Renal denervation
Renal denervation using Symplicity Catheter system
Intervention: Device: Renal denervation using Symplicity Catheter system
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 17, 2020)
41
Original Estimated Enrollment
 (submitted: September 18, 2012)
100
Actual Study Completion Date December 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
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
Principal Investigator: Roland E Schmieder, MD University of Erlangen-Nürnberg
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date February 2020