- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01737138
Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension (RSD4CKD)
2012년 11월 30일 업데이트: Qijun Shan, The First Affiliated Hospital with Nanjing Medical University
Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension
To study whether renal sympathetic denervation(RSD) is safe and effective in patients with chronic kidney disease and resistant hypertension
연구 개요
상세 설명
Chronic kidney disease(CKD) is a global and growing public health problem, and its frequency increases with age.
The major complications of CKD involve losing renal function and cardiovascular disease, which result in significant morbidity, mortality, and cost.
The main measures for treatment of CKD are optimizing drug therapy and renal replacement therapy.
Optimizing drug therapy, including vascular angiotensin-converting enzyme inhibitors, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on.
However, the situation for treatment of CKD is not satisfying.
Sympathetic overactivity plays a key role in the development and progression of CKD.
Sympathetic nerve activity was increased in patients with all stages of CKD, which was associated with cardiovascular events and all-cause mortality.
At the same time, hypertension and proteinuria become the most important risk factor for progression of CKD.
Recently, many clinical researches have verified that Catheter-based renal sympathetic denervation can safely be used to substantially reduce muscle and whole-body sympathetic-nerve activity (MSNA) and whole-body norepinephrine spillover.
Simultaneously, a marked reduction in blood pressure, sleep apnea severity and urine micro albumin level is apparent, with a improvement glucose tolerance.
Sympathetic activation, high norepinephrine level, hypertension, glucose tolerance abnormity, proteinuria and obstructive sleep apnea are all recognized as independent risk factors for the development and progression of CKD.
So, we design this randomized parallel control clinical study to demonstrate whether RSD can slow the progression of CKD and reduce the rate of all-cause mortality effectively and securely.
연구 유형
중재적
등록 (예상)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Jiangsu
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Nanjing, Jiangsu, 중국, 210000
- 모병
- First Affiliated Hospital of Nanjing Medical University
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연락하다:
- Shan Qi Jun, Professor
- 전화번호: 0086 025 68136407
- 이메일: qjshan@njmu.edu.cn
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수석 연구원:
- Shan Qi Jun, Professor
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수석 연구원:
- Xing Ch Ying, Professor
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수석 연구원:
- Chen Chun, Professor
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부수사관:
- Zhou X Juan, Professor
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부수사관:
- Qian W Chong, Professor
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부수사관:
- Liu Jia, Professor
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부수사관:
- Yu X Bao, Professor
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부수사관:
- Mao H Juan, Professor
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부수사관:
- Yao Jing, Doctor
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부수사관:
- Xu X Qiang, Doctor
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부수사관:
- Wang X Mei, Nurse
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부수사관:
- Duan X Yan, Master
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부수사관:
- Qiu Min, Master
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부수사관:
- Geng Jie, Master
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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
설명
Inclusion Criteria:
- Subject is ≥ 18 and ≤75 years of age.
- A serum creatinine level of 1.5 to 5.0 mg per deciliter (133 to 442 μmol per liter), a creatinine clearance of 20 to 70 ml per minute per 1.73 m2, with variations of less than 30 percent in the three months before randomization.
- Persistent proteinuria (defined by urinary protein excretion of more than 0.3 g per day for three or more months which can evacuate urinary tract infection and overt heart failure [a New York Heart Association class of III or IV]).
- Resistant hypertension.
- Nondiabetic renal disease.
- Subject is willing and able to comply with the protocol
- Subject is expected to remain available for follow-up visits at the study center
- Subject Informed Consent.
Exclusion Criteria:
- Current treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive drugs.
- Connective-tissue disease.
- Obstructive uropathy.
- Congestive heart failure (New York Heart Association class III or IV).
- Subject has significant renovascular abnormalities (a history of prior renal artery intervention, including balloon angioplasty or stenting; double renal artery on one side, distortion, and extension ), measured by abdominal ultrasound or renal angiograms.
- Subject has a history of myocardial infarction, unstable angina, cerebrovascular accident or alimentary tract hemorrhage in the previous 3 months.
- Subject with sick sinus syndrome.
- Subject has a history of allergy to contrast media; psychiatric disorders; drug or alcohol abuse; and pregnancy.
- Enrolled in a concurrent study that may confound the results of this study
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: RSD+Medicine
The investigators will recruit 50 randomised CKD patients who meet the inclusion criteria.
First undergo renal artery angiography procedure to confirm anatomy.
If renal artery meet the inclusion criteria, give the renal sympathetic denervation.
At the same time, we will use optimal medication to protect renal function.
Then we will conduct a clinic follow-up and a telephone follow-up e(Total 36 months).
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Contrast renal angiography(iodixanol) was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD.
Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool,Biosense Webster, Diamond Bar, California) was introduced into each renal artery.
then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis.
About six to nine ablations at 10 W for 1 min each were performed in both renal arteries.
During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
다른 이름들:
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위약 비교기: Medicine
The investigators aslo will recruit 50 randomised CKD patients who meet the inclusion criteria.
There are no significant differences in age, gender, race, past medical history,personal history and so on between the two groups.
In this group we will use optimal medication just like the RSD+Medicine group.
Third we will conduct a clinic and a telephone follow-up(Total 36 months).
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Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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All-cause mortality, doubling of the serum creatinine level or end-stage renal disease
기간: 36 months
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To study the effect of renal sympathetic denervation(RSD) on all-cause mortality,doubling of the serum creatinine level or end-stage renal disease in patients with chronic kidney disease and resistant hypertension.
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36 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Urinary protein excretion and renal function
기간: 36 months
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To evaluation of urinary protein excretion and renal function over time, by the reciprocal of the serum and urinary creatinine level, creatinine clearance and the glomerular filtration rate.
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36 months
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Blood pressure
기간: 36 months
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To study the effect of renal sympathetic denervation on blood pressure in patients with hypertension, which can be measured by ambulatory blood pressure and home blood pressure monitoring.
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36 months
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Blood sugar
기간: 36 months
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In order to study whether RSD can reduce the blood sugar level and insulin resistance of diabetic patients.
It will be measured by fasting blood glucose, glycated hemoglobin, fasting insulin .
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36 months
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Cardiac function and structure
기간: 36 months
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The effect of renal sympathetic denervation(RSD) on cardiac function and structure can be measured by echocardiographic(include the degree of cardiac pachynesis, left ventricular ejection fraction,left ventricular end diastolic diameter, ventricular septal thickness and so on).
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36 months
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Arrhythmia
기간: 36 months
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If a new arrhythmia is discovered during the follow-up, it will be recorded.
Patients may have symptoms of flustered, palpitations, dizziness, amaurosis, syncope and so on, which can be diagnosed by ECG and Holter.
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36 months
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Pulse wave velocity
기간: 36 months
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So as to study whether RSD can improve the patients' blood vessel elasticity, a pulse wave velocity (PWV)will be carried on.
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36 months
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Life quality
기간: 36 months
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Life quality on 36-item short-form(SF-36),HRQoL and PRODISQ Health Survey Questionnaire will be carried out during the follow-up to study the patients' life quality.
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36 months
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Rehospitalization rate
기간: 36 months
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To study whether RSD can reduce the patients' rehospitalization rate, which will be measured by questionnaire and telephone follow-ups.
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36 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Dialysis
기간: 36 months
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In order to study the effect of renal sympathetic denervation on renal function in patients with dialysis, which can be measured by the proportion of patients who do not need dialysis anymore.
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36 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Shan Qi Jun, professor, The First Affiliated Hospital with Nanjing Medical University
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
2012년 11월 1일
기본 완료 (예상)
2017년 8월 1일
연구 완료 (예상)
2018년 4월 1일
연구 등록 날짜
최초 제출
2012년 11월 27일
QC 기준을 충족하는 최초 제출
2012년 11월 27일
처음 게시됨 (추정)
2012년 11월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 12월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 11월 30일
마지막으로 확인됨
2012년 11월 1일
추가 정보
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. .
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