Status:
RECRUITING
Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN
Lead Sponsor:
Shenzhen Pulsecare Medical Technology Co., Ltd.
Conditions:
Refractory Hypertension or Drug-intolerant Hypertension
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Prospective, multicenter, randomized, controlled, blinded, and superiority - designed; The target population undergoes a screening treatment with prescribed medications for at least 4 weeks. Eligible ...
Eligibility Criteria
Inclusion
- Age between 18 and 70 years old (calculated based on the date of starting standardized medication).
- After treatment with at least two types of antihypertensive drugs for 4 weeks or more, the clinic systolic blood pressure is ≥140 mmHg and ≤180 mmHg, and the average 24 - hour ambulatory systolic blood pressure is ≥130 mmHg (or the daytime ambulatory systolic blood pressure is ≥135 mmHg).
- Resting heart rate ≥70 beats per minute without taking beta - blockers (this criterion does not apply to patients taking beta - blockers).
- The subject agrees to participate in this clinical trial, complies with the follow - up required by the trial protocol, and has voluntarily signed the informed consent form
Exclusion
- CTA, MRA, or DSA examination shows that the shape and structure of the unilateral or bilateral renal arteries are not suitable for ablation surgery (renal artery stenosis exceeding 50%, renal artery aneurysm, fibromuscular dysplasia of the renal artery, or the diameter of the main renal artery is less than 3 mm).
- Having only one kidney or having received a kidney transplant.
- Having a history of renal artery interventional treatment or renal denervation surgery.
- Suffering from any condition that may affect the accuracy of blood pressure measurement, such as the upper arm diameter being too large relative to the cuff.
- Secondary hypertension (excluding apnea syndrome).
- Glomerular filtration rate (eGFR) \< 45 mL/min/1.73m² (MDRD formula).
- Having a history of hospitalization due to hypertensive crisis within one year before randomization for enrollment.
- Suffering from type 1 diabetes.
- Suffering from primary pulmonary hypertension.
- Being allergic to contrast agents.
- Severe cardiac valve stenosis.
- Cardiac insufficiency (NYHA class III - IV).
- Hyperthyroidism or hypothyroidism.
- Requiring mechanical ventilation for assisted breathing (except for nocturnal respiratory support for treating sleep apnea).
- Acute or severe systemic infection.
- Having an implantable cardioverter - defibrillator (ICD) or pacemaker.
- Having obvious symptoms of active peptic ulcer (such as abdominal pain, nausea, vomiting, regurgitation, etc.).
- Having obvious bleeding tendency and hematological diseases.
- Having a history of surgery or trauma requiring hospitalization within 30 days before randomization for enrollment.
- Having a cardiovascular event (stable or unstable angina, myocardial infarction) or cerebrovascular event (stroke, cerebrovascular accident, transient ischemic attack) within 6 months before randomization for enrollment.
- Pregnant, lactating women, or women planning to become pregnant during the study period.
- Currently participating in other clinical trials of drugs or medical devices.
- Other reasons that the investigator deems inappropriate for participation in this study
Key Trial Info
Start Date :
January 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06877221
Start Date
January 25 2025
End Date
December 1 2030
Last Update
June 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China