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Renal Nerve Ablation in Chronic Kidney Disease Patients

25 marzo 2020 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

27

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

treatment resistant hypertensive adults with chronic kidney disease 3 - 5

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
office BP
Lasso di tempo: baseline, 6 months
Change in office blood pressure from baseline to 6 months post-renal nerve ablation
baseline, 6 months
24-h ABPM
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
BP
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigatori

  • Investigatore principale: Roland E Schmieder, MD, University of Erlangen-Nürnberg, Germany

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2010

Completamento primario (Effettivo)

1 giugno 2019

Completamento dello studio (Effettivo)

1 giugno 2019

Date di iscrizione allo studio

Primo inviato

22 settembre 2011

Primo inviato che soddisfa i criteri di controllo qualità

28 settembre 2011

Primo Inserito (Stima)

29 settembre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 marzo 2020

Ultimo verificato

1 marzo 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RNA-CKD3-5

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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