Hypertension
Conditions
Interventions
treatment group:Ultrasound ablation of renal artery sympathetic nervous system
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) aged 18-75 years old; (2) uncontrolled essential hypertension; (3) According to the prescription, after 28 days of antihypertensive drug screening and treatment, the clinic systolic blood pressure was =150mmHg and =180mmHg, or the clinic diastolic blood pressure was >=90mmHg; (4) At the same time, 24-hour systolic blood pressure =135mmHg; (5) duration of hypertension more than 6 months; (6) Patients or their legal representatives provided written informed consent approved by the ethics committee before screening;
Exclusion criteria
Exclusion criteria: (1) secondary hypertension patients; (2) previous history of renal artery interventional therapy, such as stent; Renal artery lesions or morphological variations, including aneurysm, stenosis, severe renal artery calcification, dissection, multiple renal arteries, etc. (3) History of myocardial infarction, unstable angina pectoris, syncope, cerebrovascular accident, intermittent claudication, extensive atherosclerosis with intravascular thrombosis within the last 4 months; (4) heart valve disease with significant hemodynamic changes; (5) complicated with refractory pulmonary hypertension; (6) glomerular filtration rate (eGFR) 50.1); (8) patients with ICD history or pacemaker implantation; (9) acute or severe systemic infection; (10) patients with type ? diabetes mellitus; (11) patients with severe respiratory diseases requiring long-term oxygen therapy or mechanical ventilation; (12) contrast agent allergy; (13) pregnant or lactating women and those who planned to have children in the next year; (14) alcohol and other drug addicts and mental patients; (15) The presence of other diseases that may adversely affect the safety of subjects or clinical research; (16) patients who had participated in clinical trials of other drugs or devices; (17) contraindications to use renal artery ultrasound ablation catheter (main renal artery stenosis diameter 50% on either side, contraindications to interventional therapy, blood system diseases, infection and unsuitable for ablation procedure); (18) Patients who were not considered to be eligible for the study by the investigator. Imaging exclusion criteria (preoperative CTA or MRA) : (19) renal artery diameter stenosis > 50% on either side; (20) renal artery trunk diameter 8mm or renal artery length < 20mm;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-h ambulatory diurnal mean systolic blood pressure change from baseline(pre-operation); | — |
Secondary
| Measure | Time frame |
|---|---|
| Office systolic blood pressure change from baseline(pre-operation);24-hour ambulatory diurnal mean diastolic blood pressure change from baseline(pre-operation);Change from baseline in office diastolic blood pressure(pre-operation);Two months after surgery, the rate of office systolic blood pressure reaching the target was calculated; | — |
Countries
China
Contacts
Public ContactGe Junbo
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed