Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN

Launched by SHENZHEN PULSECARE MEDICAL TECHNOLOGY CO., LTD. · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for people who have high blood pressure that is hard to control, known as refractory hypertension, or for those who cannot tolerate common blood pressure medications. The study will compare two groups of participants: one group will receive a special ultrasound treatment aimed at reducing nerve signals that raise blood pressure, while the other group will undergo a procedure that mimics the treatment but does not actually involve the ultrasound (this is called a sham operation). Both groups will continue taking their usual blood pressure medications for six months, and researchers will measure how well each treatment works by checking changes in their blood pressure.

To participate in the trial, individuals must be between 18 and 70 years old and have tried at least two different blood pressure medications for at least four weeks without satisfactory results. They should have a specific range of blood pressure measurements to qualify. However, certain health conditions, such as serious kidney problems or recent heart issues, may prevent someone from being eligible. It's important for participants to commit to follow-up appointments and to have signed consent to join the study. This trial is not yet recruiting participants, so there will be more information available when the study begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 70 years old (calculated based on the date of starting standardized medication).
• • 2. 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).
• • 3. Resting heart rate ≥70 beats per minute without taking beta - blockers (this criterion does not apply to patients taking beta - blockers).
• • 4. 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 Criteria:
• • 1. 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).
• • 2. Having only one kidney or having received a kidney transplant.
• • 3. Having a history of renal artery interventional treatment or renal denervation surgery.
• • 4. 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.
• • 5. Secondary hypertension (excluding apnea syndrome).
• • 6. Glomerular filtration rate (eGFR) \< 45 mL/min/1.73m² (MDRD formula).
• • 7. Having a history of hospitalization due to hypertensive crisis within one year before randomization for enrollment.
• • 8. Suffering from type 1 diabetes.
• • 9. Suffering from primary pulmonary hypertension.
• • 10. Being allergic to contrast agents.
• • 11. Severe cardiac valve stenosis.
• • 12. Cardiac insufficiency (NYHA class III - IV).
• • 13. Hyperthyroidism or hypothyroidism.
• • 14. Requiring mechanical ventilation for assisted breathing (except for nocturnal respiratory support for treating sleep apnea).
• • 15. Acute or severe systemic infection.
• • 16. Having an implantable cardioverter - defibrillator (ICD) or pacemaker.
• • 17. Having obvious symptoms of active peptic ulcer (such as abdominal pain, nausea, vomiting, regurgitation, etc.).
• • 18. Having obvious bleeding tendency and hematological diseases.
• • 19. Having a history of surgery or trauma requiring hospitalization within 30 days before randomization for enrollment.
• • 20. 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.
• • 21. Pregnant, lactating women, or women planning to become pregnant during the study period.
• • 22. Currently participating in other clinical trials of drugs or medical devices.
• • 23. Other reasons that the investigator deems inappropriate for participation in this study