Actively Recruiting
Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN
Led by Shenzhen Pulsecare Medical Technology Co., Ltd. · Updated on 2025-06-19
204
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multicenter, randomized, controlled, blinded, and superiority - designed; The target population undergoes a screening treatment with prescribed medications for at least 4 weeks. Eligible subjects are randomly assigned to the experimental group and the control group at a ratio of 2:1. The experimental group is treated with the ultrasound nerve ablation catheter and the ultrasound nerve ablation device of Shenzhen Maiwei Medical Technology Co., Ltd., while the control group only undergoes renal arteriography (regarded as a sham operation). Within 6 months after the operation, both groups continue to receive antihypertensive drug treatment with the dosage and types specified during the screening period. The subjects are kept blinded during the study. The relative change values of the average 24 - hour ambulatory systolic blood pressure from the baseline at 6 months after the operation are compared between the two groups.
CONDITIONS
Official Title
Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old based on the start date of standardized medication
- Treated with at least two types of antihypertensive drugs for 4 weeks or more
- Clinic systolic blood pressure between 140 mmHg and 180 mmHg
- Average 24-hour ambulatory systolic blood pressure at least 130 mmHg or daytime ambulatory systolic blood pressure at least 135 mmHg
- Resting heart rate at least 70 beats per minute without beta-blockers (not applicable if taking beta-blockers)
- Willing to participate, comply with follow-up, and have signed informed consent
You will not qualify if you...
- Unilateral or bilateral renal artery abnormalities unsuitable for ablation surgery, including stenosis over 50%, aneurysm, fibromuscular dysplasia, or main renal artery diameter less than 3 mm
- Having only one kidney or a kidney transplant
- Previous renal artery intervention or renal denervation surgery
- Conditions affecting blood pressure measurement accuracy, like an upper arm too large for the cuff
- Secondary hypertension except for apnea syndrome
- Glomerular filtration rate below 45 mL/min/1.73m²
- Hospitalization for hypertensive crisis within one year before enrollment
- Type 1 diabetes
- Primary pulmonary hypertension
- Allergy to contrast agents
- Severe cardiac valve stenosis
- Cardiac insufficiency classified as NYHA III-IV
- Hyperthyroidism or hypothyroidism
- Need for mechanical ventilation except nocturnal respiratory support for sleep apnea
- Acute or severe systemic infection
- Having an implantable cardioverter-defibrillator or pacemaker
- Active peptic ulcer symptoms
- Bleeding tendency or blood disorders
- Surgery or trauma requiring hospitalization within 30 days before enrollment
- Cardiovascular or cerebrovascular events within 6 months before enrollment
- Pregnant, lactating, or planning pregnancy during the study
- Participation in other clinical trials
- Other reasons deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China
Actively Recruiting
Research Team
J
Jingfeng J wang, Postdoctoral fellow
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here