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Renal Nerve Ablation in Chronic Kidney Disease Patients

25 de março de 2020 atualizado por: University of Erlangen-Nürnberg Medical School

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

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

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

27

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Erlangen, Alemanha, 91054
        • Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
      • Lübeck, Alemanha
        • Joachim Weil

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

treatment resistant hypertensive adults with chronic kidney disease 3 - 5

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
treatment resistant hypertensives with CKD 3-5
Dispositivo: Simplicity Catheter
percutaneous selective renal sympathetic nerve ablation with the use of the Simplicity Catheter system

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
office BP
Prazo: baseline, 6 months
Change in office blood pressure from baseline to 6 months post-renal nerve ablation
baseline, 6 months
24-h ABPM
Prazo: baseline, 6 months
Change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal nerve ablation
baseline, 6 months
Magnetic resonance imaging (MRI)
Prazo: 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
baseline, 6 months
Albuminuria
Prazo: baseline, 6 months
Change in urinary albumin/creatinine ratio from baseline to 6 months post renal nerve ablation (spot urine)
baseline, 6 months
local RAS activity
Prazo: baseline, 6 months
Change in urinary angiotensinogen concentration from the morning spot urine from baseline to 6 months post-renal nerve ablation
baseline, 6 months
systemic RAS activity
Prazo: 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
baseline, 6 months
vascular structure and function of large and small arteries
Prazo: 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
baseline, 6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
BP
Prazo: 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
1 and 12 months
local RAS activity
Prazo: 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
1 day and 1 months
systemic RAS activity
Prazo: 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
1 day and 1 months
vascular structure and function of large and small arteries
Prazo: 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
12 months
MRI
Prazo: 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
1 day, 1 and 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Erlangen-Nürnberg Medical School

Investigadores

  • Investigador principal: Roland E Schmieder, MD, University of Erlangen-Nürnberg, Germany

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de novembro de 2010

Conclusão Primária (Real)

1 de junho de 2019

Conclusão do estudo (Real)

1 de junho de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

22 de setembro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de setembro de 2011

Primeira postagem (Estimativa)

29 de setembro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de março de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de março de 2020

Última verificação

1 de março de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RNA-CKD3-5

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