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Renal Nerve Ablation in Chronic Kidney Disease Patients

2020년 3월 25일 업데이트: 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

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (실제)

27

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

treatment resistant hypertensive adults with chronic kidney disease 3 - 5

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
treatment resistant hypertensives with CKD 3-5
장치: Simplicity Catheter
percutaneous selective renal sympathetic nerve ablation with the use of the Simplicity Catheter system

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
office BP
기간: baseline, 6 months
Change in office blood pressure from baseline to 6 months post-renal nerve ablation
baseline, 6 months
24-h ABPM
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
BP
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Erlangen-Nürnberg Medical School

수사관

  • 수석 연구원: Roland E Schmieder, MD, University of Erlangen-Nürnberg, Germany

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2010년 11월 1일

기본 완료 (실제)

2019년 6월 1일

연구 완료 (실제)

2019년 6월 1일

연구 등록 날짜

최초 제출

2011년 9월 22일

QC 기준을 충족하는 최초 제출

2011년 9월 28일

처음 게시됨 (추정)

2011년 9월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 3월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 3월 25일

마지막으로 확인됨

2020년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RNA-CKD3-5

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Simplicity Catheter에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in United States

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다