Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension (RSD4CKD)
2012年11月30日 更新者：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
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Jiangsu
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Nanjing、Jiangsu、中国、210000
- 募集
- First Affiliated Hospital of Nanjing Medical University
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コンタクト：
- Shan Qi Jun, Professor
- 電話番号：0086 025 68136407
- メール：qjshan@njmu.edu.cn
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主任研究者：
- Shan Qi Jun, Professor
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主任研究者：
- Xing Ch Ying, Professor
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主任研究者：
- Chen Chun, Professor
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副調査官：
- Zhou X Juan, Professor
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副調査官：
- Qian W Chong, Professor
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副調査官：
- Liu Jia, Professor
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副調査官：
- Yu X Bao, Professor
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副調査官：
- Mao H Juan, Professor
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副調査官：
- Yao Jing, Doctor
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副調査官：
- Xu X Qiang, Doctor
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副調査官：
- Wang X Mei, Nurse
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副調査官：
- Duan X Yan, Master
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副調査官：
- Qiu Min, Master
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副調査官：
- Geng Jie, Master
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
他の名前：
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プラセボコンパレーター：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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All-cause mortality, doubling of the serum creatinine level or end-stage renal disease
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Urinary protein excretion and renal function
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dialysis
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Shan Qi Jun, professor、The First Affiliated Hospital with Nanjing Medical University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年11月1日
一次修了 (予想される)
2017年8月1日
研究の完了 (予想される)
2018年4月1日
試験登録日
最初に提出
2012年11月27日
QC基準を満たした最初の提出物
2012年11月27日
最初の投稿 (見積もり)
2012年11月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年12月3日
QC基準を満たした最後の更新が送信されました
2012年11月30日
最終確認日
2012年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。