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Completed

NCT Number: NCT01687725

Renal Denervation in Treatment Resistant Hypertension

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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Key information

Conditions

Hypertension Cardiovascular 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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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Renal denervation using Symplicity Catheter system

Device

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

Primary outcomes

  1. office BP

    Time frame: baseline, 6 months

    change in office blood pressure from baseline to 6 months post-renal denervation

  2. 24-ABPM

    Time frame: baseline, 6 months

    change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal denervation

  3. 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

  4. Albuminuria

    Time frame: baseline, 6 months

    change in urinary albumin/creatinine ratio from baseline to 6 months post-renal denervation

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Albuminuria

    Time frame: 3 and 12 months

    • change in albuminuria from baseline to 3 and 12 months post-renal denervation

  6. 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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Sep 19, 2012
Registry last updated
Feb 18, 2020

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

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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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