Clinical trial NCT01737138: Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension
Official title: Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Resistant hypertension
All-cause mortality
Renal function
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study whether renal sympathetic denervation(RSD) is safe and effective in patients with chronic kidney disease and resistant hypertension

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 18 and ≤75 years of age.
2. 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.
3. 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 \[a New York Heart Association class of III or IV\]).
4. Resistant hypertension.
5. Nondiabetic renal disease.
6. Subject is willing and able to comply with the protocol
7. Subject is expected to remain available for follow-up visits at the study center
8. Subject Informed Consent.

Exclusion Criteria:

1. Current treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive drugs.
2. Connective-tissue disease.
3. Obstructive uropathy.
4. Congestive heart failure (New York Heart Association class III or IV).
5. 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.
6. Subject has a history of myocardial infarction, unstable angina, cerebrovascular accident or alimentary tract hemorrhage in the previous 3 months.
7. Subject with sick sinus syndrome.
8. Subject has a history of allergy to contrast media; psychiatric disorders; drug or alcohol abuse; and pregnancy.
9. Enrolled in a concurrent study that may confound the results of this study

Primary outcomes:
measure: All-cause mortality, doubling of the serum creatinine level or end-stage renal disease
timeFrame: 36 months
Secondary outcomes:
measure: Urinary protein excretion and renal function
timeFrame: 36 months
measure: Blood pressure
timeFrame: 36 months
measure: Blood sugar
timeFrame: 36 months
measure: Cardiac function and structure
timeFrame: 36 months
measure: Arrhythmia
timeFrame: 36 months
measure: Pulse wave velocity
timeFrame: 36 months
measure: Life quality
timeFrame: 36 months
measure: Rehospitalization rate
timeFrame: 36 months
Other outcomes:
measure: Dialysis
timeFrame: 36 months
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shan Qi Jun, professor
role: STUDY_CHAIR
References: