Overview
Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension
Status:
Unknown status
Unknown status
Trial end date:
2018-04-01
2018-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To study whether renal sympathetic denervation(RSD) is safe and effective in patients with chronic kidney disease and resistant hypertensionPhase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
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