Primary and CKD Hypertension
Conditions
Interventions
Treatment Group:Renal Denervation
Control Group:Sham Operation
Sponsors
Capital Medical University Affiliated AnZhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, male or female; 2. Patients who have been taking 2 or more anti-hypertensive drugs for at least 4 weeks, with mean BP =150/90 mmHg based on 3 office blood pressure measurements, or ASBP=135 mmHg based on 24 hr blood pressure monitoring; 3. Heart beats at rest =70 bpm 4. Confirmed diagnosis of primary hypertension or CKD hypertension; 5. Main renal artery, with or without accessary renal arteries; 6. Agree to take part in the trial and signs the written, informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or plan to become pregnant, or Breastfeeding; 2. Renal artery abnormalities that are inappropriate for the procedure (renal stenosis =50%, aneurysm, renal artery diameter <4mm or length<20mm); 3. Only one kidney or kidney transplant recipient; 4. Prior renal artery interventional procedures or prior RDN treatment; 5. Any conditions affecting accuracy of blood pressure measurement, such as diameter of upper arm too large for the cuff or severe arrhythmia; 6. Secondary hypertension other than CKD hypertension; 7. Pseudohypertension; 8. History of orthostatic hypotension; 9. Average systolic blood pressure (ASBP) <135mmHg based on ambulatory 24 hours blood pressure monitoring; 10. History of hospitalization for hypertensive emergencies within one year; 11. Type I diabetes; 12. Primary pulmonary hypertension; 13. Bleeding tendency or other coagulation related diseases; 14. Abnormal blood electrolytes levels; 15. History of stroke or transit ischemic attack (TIA) within 2 weeks; 16. Malignant tumor or end-stage illnesses; 17. Severe peripheral vascular diseases, aneurysm; 18. Acute coronary events within 2 weeks; 19. Patients who need assisted breathing with mechanical ventilation; 20. Acute or severe systemic infection; 21. Patients with pacemaker implantation; 22. Major surgery or trauma in 30 days before enrollment; 23. Plan to receive surgery or cardiovascular interventional procedures in 6 months; 24. Have been enrolled for other drug or device trial; 25. Known drug or alcohol dependency, unable to comprehend the trial protocol, unwilling or unable to comply with follow-ups in accordance with the protocol; 26. Other conditions that deem unsuitable for the procedure, in the opinions of investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure; | — |
Countries
China
Contacts
Public ContactZhou Yujie
AnZhen Hospital
Outcome results
None listed