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NCT Number: NCT01442883

Renal Nerve Ablation in Chronic Kidney Disease Patients

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simplicity Catheter

Device

percutaneous selective renal sympathetic nerve ablation with the use of the Simplicity Catheter system

Primary outcomes

  1. office BP

    Time frame: baseline, 6 months

    Change in office blood pressure from baseline to 6 months post-renal nerve ablation

  2. 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

  3. 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

  4. Albuminuria

    Time frame: baseline, 6 months

    Change in urinary albumin/creatinine ratio from baseline to 6 months post renal nerve ablation (spot urine)

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Understanding the Mechanisms of Progressive Decrease in Blood Pressure After Renal Nerve Ablation

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Sep 29, 2011
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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