Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN

Официальное название

A Prospective, Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Effectiveness and Safety of an Ultrasound Renal Denervation Catheter in Combination With an Ultrasound Renal Denervation Device for the Treatment of Refractory Hypertension or Drug - Intolerant Hypertension

Обзор

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.

Вмешательства

• Процедура ultrasound renal denervation
  Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device

Первичные конечные точки

• The average change value of 24 - hour ambulatory systolic blood pressure (ASBP) relative to the baseline [Срок оценки: Six months after surgery]

Вторичные конечные точки (6)

• The change values of clinic systolic blood pressure and diastolic blood pressure relative to the baseline [Срок оценки: 3 months and 6 months after surgery]
• The attainment rate of clinic diastolic blood pressure [Срок оценки: 3 months and 6 months after surgery]
• The average change value of 24 - hour ambulatory diastolic blood pressure relative to the baseline [Срок оценки: 3 months and 6 months after surgery]
• The average change value of 24 - hour ambulatory systolic blood pressure relative to the baseline [Срок оценки: Three months after surgery]
• The proportion of patients with a reduction in clinic systolic blood pressure of ≥5 mmHg, 10 mmHg, 15 mmHg, and 20 mmHg [Срок оценки: 3 months and 6 months after surgery]
• Changes in the drug composite index of the types and dosages of antihypertensive medications [Срок оценки: Six months after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT06877221 · MW-URDN202501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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