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Renal Nerve Ablation in Chronic Kidney Disease Patients

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ClinicalTrials.gov Identifier: NCT01442883
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Tracking Information
First Submitted Date September 22, 2011
First Posted Date September 29, 2011
Last Update Posted Date March 26, 2020
Actual Study Start Date November 2010
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 18, 2013)
  • office BP [ Time Frame: baseline, 6 months ]
    Change in office blood pressure from baseline to 6 months post-renal nerve ablation
  • 24-h ABPM [ Time Frame: baseline, 6 months ]
    Change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal nerve ablation
  • Magnetic resonance imaging (MRI) [ Time Frame: baseline, 6 months ]
    • change in total sodium content measured by MRI from baseline to 6 months post-renal nerve ablation
    • change in renal perfusion measured by MRI spin labelling technique from baseline to 6 months post-renal nerve ablation
  • Albuminuria [ Time Frame: baseline, 6 months ]
    Change in urinary albumin/creatinine ratio from baseline to 6 months post renal nerve ablation (spot urine)
  • 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 nerve ablation
  • systemic RAS activity [ Time Frame: baseline, 6 months ]
    • change in sodium, potassium and creatinine from baseline to 6 months post-renal nerve ablation
    • change in aldosterone excretion from baseline to 6 months post-renal nerve ablation
    • change in sodium / potassium ratio from baseline to 6 months post-renal nerve ablation
    • 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 nerve ablation
  • 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 nerve ablation
    • change in scanning laser Doppler flowmetry (SLDF) from baseline to 6 months post-renal nerve ablation
    • change in pulse wave analysis (PWA) from baseline to 6 months post-renal nerve ablation
    • change in pulse wave velocity from (PWV) baseline to 6 months post-renal nerve ablation
    • change in urinary albumine creatinine ratio (UACR) of the morning spot urine sample from baseline to 6 months post-renal nerve ablation
Original Primary Outcome Measures
 (submitted: September 28, 2011)
  • office BP [ Time Frame: baseline, 6 months ]
    Change in office blood pressure from baseline to 6 months post-renal nerve ablation
  • 24-h ABPM [ Time Frame: baseline, 6 months ]
    Change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal nerve ablation
  • Magnetic resonance imaging (MRI) [ Time Frame: baseline, 6 months ]
    • change in total sodium content mesasured by MRI from baseline to 6 months post-renal nerve ablation
    • change in renal perfusion measured by MRI spin labelling technique from baseline to 6 months post-renal nerve ablation
  • Albuminuria [ Time Frame: baseline, 6 months ]
    Change in urinary albumin/creatinine ratio from baseline to 6 months post renal nerve ablation (spot urine)
  • 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 nerve ablation
  • systemic RAS activity [ Time Frame: baseline, 6 months ]
    • change in sodium, potassium and creatinine from baseline to 6 months post-renal nerve ablation
    • change in aldosterone excretion from baseline to 6 months post-renal nerve ablation
    • change in sodium / potassium ratio from baseline to 6 months post-renal nerve ablation
    • 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 nerve ablation
  • 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 nerve ablation
    • change in scanning laser Doppler flowmetry (SLDF) from baseline to 6 months post-renal nerve ablation
    • change in pulse wave analysis (PWA) from baseline to 6 months post-renal nerve ablation
    • change in pulse wave velocity from (PWV) baseline to 6 months post-renal nerve ablation
    • change in urinary albumine creatinine ratio (UACR) of the morning spot urine sample from baseline to 6 months post-renal nerve ablation
Change History
Current Secondary Outcome Measures
 (submitted: January 18, 2013)
  • BP [ Time Frame: 1 and 12 months ]
    • change in office blood pressure from baseline to 1 and 12 months post-renal nerve ablation
    • change in 24 hour ambulatory blood pressure from baseline to 1 and 12 months post-renal nerve ablation
  • local RAS activity [ Time Frame: 1 day and 1 months ]
    Change in urinary angiotensinogen concentration from the morning spot urine from baseline to 1 day and 1 months post-renal nerve ablation
  • systemic RAS activity [ Time Frame: 1 day and 1 months ]
    • change in sodium, potassium and creatinine from baseline to 1 day and 1 months post-renal nerve ablation
    • change in albuminuria from baseline to 1 and 12 months post-renal nerve ablation
    • change in aldosterone excretion from baseline to 1 day and 1 months post-renal nerve ablation
    • change in sodium / potassium ratio from baseline to 1 day and 1 months post-renal nerve ablation
    • 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 and 1 months post-renal nerve ablation
  • vascular structure and function of large and small arteries [ Time Frame: 12 months ]
    • change in flow-mediated vasodilation (FMD) from baseline to 12 months post-renal nerve ablation
    • change in scanning laser Doppler flowmetry (SLDF) from baseline to 12 months post-renal nerve ablation
    • change in pulse wave analysis (PWA) from baseline to 12 months post-renal nerve ablation
    • change in pulse wave velocity from (PWV) baseline to 12 months post-renal nerve ablation
    • change in urinary albumine creatinine ratio (UACR) of the morning spot urine sample from baseline to 12 months post-renal nerve ablation
  • MRI [ Time Frame: 1 day, 1 and 12 months ]
    • change in total sodium content measured by MRI from baseline to 12 months post-renal nerve ablation
    • change in renal perfusion measured by MRI spin labelling technique from baseline to 1 day and 1 months post-renal nerve ablation
Original Secondary Outcome Measures
 (submitted: September 28, 2011)
  • BP [ Time Frame: 1 and 12 months ]
    • change in office blood pressure from baseline to 1 and 12 months post-renal nerve ablation
    • change in 24 hour ambulatory blood pressure from baseline to 1 and 12 months post-renal nerve ablation
  • local RAS activity [ Time Frame: 1 day and 1 months ]
    Change in urinary angiotensinogen concentration from the morning spot urine from baseline to 1 day and 1 months post-renal nerve ablation
  • systemic RAS activity [ Time Frame: 1 day and 1 months ]
    • change in sodium, potassium and creatinine from baseline to 1 day and 1 months post-renal nerve ablation
    • change in albuminuria from baseline to 1 and 12 months post-renal nerve ablation
    • change in aldosterone excretion from baseline to 1 day and 1 months post-renal nerve ablation
    • change in sodium / potassium ratio from baseline to 1 day and 1 months post-renal nerve ablation
    • 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 and 1 months post-renal nerve ablation
  • vascular structure and function of large and small arteries [ Time Frame: 12 months ]
    • change in flow-mediated vasodilation (FMD) from baseline to 12 months post-renal nerve ablation
    • change in scanning laser Doppler flowmetry (SLDF) from baseline to 12 months post-renal nerve ablation
    • change in pulse wave analysis (PWA) from baseline to 12 months post-renal nerve ablation
    • change in pulse wave velocity from (PWV) baseline to 12 months post-renal nerve ablation
    • change in urinary albumine creatinine ratio (UACR) of the morning spot urine sample from baseline to 12 months post-renal nerve ablation
  • MRI [ Time Frame: 1 day, 1 and 12 months ]
    • change in total sodium content mesasured by MRI from baseline to 12 months post-renal nerve ablation
    • change in renal perfusion measured by MRI spin labelling technique from baseline to 1 day and 1 months post-renal nerve ablation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Renal Nerve Ablation in Chronic Kidney Disease Patients
Official Title Understanding the Mechanisms of Progressive Decrease in Blood Pressure After Renal Nerve Ablation
Brief Summary

In patients with treatment resistent 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 labelling 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 In patients with treatment resistent 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 labelling 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.
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 with chronic kidney disease 3 - 5
Condition
  • Hypertension
  • Chronic Kidney Disease
Intervention Device: Simplicity Catheter
percutaneous selective renal sympathetic nerve ablation with the use of the Simplicity Catheter system
Study Groups/Cohorts treatment resistant hypertensives with CKD 3-5
Intervention: Device: Simplicity Catheter
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: March 25, 2020)
27
Original Estimated Enrollment
 (submitted: September 28, 2011)
100
Actual Study Completion Date June 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • treatment resistant hypertension
  • chronic kidney disease 3 - 5
  • male of female aged over 18 years
  • written informed consent
  • agreement to attend all study visits as planned in the protocol

Exclusion Criteria:

  • any contraindications 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 NCT01442883
Other Study ID Numbers RNA-CKD3-5
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, Germany
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date March 2020