Uncontrolled hypertension
Conditions
Interventions
Intervention group:Use the Netrod-RDN renal artery radiofrequency ablation system
Sponsors
The Second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
19 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old=2 standardized antihypertensive drugs continuously and stably for at least 4 weeks, and the office blood pressure >=140/90mmHg, or 24-hour ambulatory blood pressure >=130/80mmHg; 3. With or without renal accessory artery; 4.eGFR>=40ml/min/1.73m^2; 5. The subject or his legal agent fully understands the informed consent content of this trial and voluntarily signs the written informed consent.
Exclusion criteria
Exclusion criteria: (1) Pregnant women, lactating women, and those planning to get pregnant; (2) Unfavorable shape and structure of unilateral or bilateral renal arteries for ablation surgery (renal artery stenosis exceeding 50%, renal artery aneurysm, renal artery malformation, renal artery diameter less than 4mm or treatable segment length less than 20mm); (3) Having only one kidney or undergoing kidney transplantation or requiring dialysis treatment; (4) Having a history of renal artery interventional therapy or having undergone renal sympathetic nerve ablation; (5) Secondary hypertension not related to kidney diseases (such as primary aldosteronism, pheochromocytoma, renal vascular hypertension, etc.); (6) Allergic to contrast agents; (7) Having a major surgical history or a history of trauma within one month before enrollment, a history of acute coronary syndrome within six months, or a planned surgery or cardiovascular interventional treatment within the next six months; (8) Orthostatic hypotension; (9) Type 1 diabetes; (10) Primary pulmonary hypertension; (11) Having obvious bleeding tendency and hematological diseases; (12) Having a history of embolism within six months; (13) Having a history of stroke or transient ischemic attack (TIA) within three months; (14) Severe peripheral vascular diseases, abdominal aortic aneurysm; (15) Severe valvular diseases or requiring surgical valve replacement during the study period; (16) Having NYHA III/IV grade heart failure at the time of screening or having been hospitalized for chronic heart failure exacerbation within the past six months; (17) Having a history of ventricular fibrillation, multifocal polymorphic ventricular tachycardia, or having a history of implantable defibrillator or cardiac pacemaker implantation; (18) Severe liver dysfunction; (19) Having other serious diseases that hinder their enrollment or affect their survival, such as malignant tumors or AIDS; (20) Having any known drug or alcohol dependence, difficulty understanding the experimental protocol, unwillingness or inability to follow the protocol for follow-up; (21) Other situations deemed inappropriate for participation in this clinical trial by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 6 months after surgery compared with the baseline values; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in systolic and diastolic blood pressure in the examination room compared with the baseline level;The changes in the usage of antihypertensive drugs compared to the baseline level;Blood pressure control rate;Time in target range (TTR) of blood pressure;The incidence of major adverse events (MAE) within 30 days after surgery;The incidence rates of the following safety events within 12 months after the surgery; | — |
Countries
China
Contacts
Public ContactLi yan
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed