Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension

NCT01737138 | Unknown DMC

• 1 other identifier: 2012-SR-142
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease

Keywords

Resistant hypertension; All-cause mortality; Renal function

Outcome Measures

Primary Outcomes (1)

• All-cause mortality, doubling of the serum creatinine level or end-stage renal disease

  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.

  36 months

Secondary Outcomes (8)

• Urinary protein excretion and renal function

  36 months

• Blood pressure

  36 months

• Blood sugar

  36 months

• Cardiac function and structure

  36 months

• Arrhythmia

  36 months

Other Outcomes (1)

• Dialysis

  36 months

Study Arms (2)

RSD+Medicine

ACTIVE COMPARATOR

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).

Procedure: RSD

Medicine

PLACEBO COMPARATOR

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).

Drug: medicine

Interventions

RSD PROCEDURE

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.

Also known as: renal sympathetic denervation, renal denervation, renal ablation

RSD+Medicine

medicine DRUG

Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on.

Also known as: drug

Medicine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Dosage Forms; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Shan Qi Jun, professor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Shan Qi jun, professor

CONTACT

0086 025 68136407; qjshan@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor，Director, Cardiac Arrhythmia Group

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: April 1, 2018
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

CN (1)