Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN（FIM）

Официальное название

An Exploratory Clinical Study on the Safety and Efficacy of the Ultrasonic Nerve Ablation System in the Treatment of Essential Hypertension

Обзор

This study is a prospective and exploratory clinical study, enrolling patients with essential hypertension. This study is planned to be conducted in 2 research institutions in China, and a total of 6 subjects are planned to be included. After the subjects sign the informed consent form (ICF) approved by the ethics committee, they will enter the screening procedure. Subjects who meet the inclusion criteria and do not meet any of the clinical exclusion criteria will be enrolled after undergoing renal artery CTA angiography. All patients will undergo clinical evaluation and blood pressure measurement during the operation, at the time of discharge, and at 1 month, 2 months, 3 months, and 6 months after the operation. It is recommended that the anti-hypertensive medications used before the operation should not be changed within 6 months after the operation for the cases. When the systolic blood pressure (SBP) is ≥ 180 mmHg or there are clinical symptoms caused by hypertension, the drug dosage should be increased as a priority, and then the anti-hypertensive medications should be adjusted. When the systolic blood pressure (SBP) is ≤ 120 mmHg or there are clinical symptoms caused by a decrease in blood pressure, the anti-hypertensive medications should be reduced.

Вмешательства

• Процедура Ultrasonic Nerve Ablation System
  Treatment of patients with essential hypertension using the ultrasonic nerve ablation system

Первичные конечные точки

• The change in the average daytime systolic blood pressure two months after the operation [Срок оценки: Two months after the operation]
• Major adverse events within 30 days after the operation [Срок оценки: Within 30 days after the operation]

Вторичные конечные точки (11)

• The changes in the average systolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation [Срок оценки: 1 month, 3 months, 6 months after the operation]
• Changes in the average diastolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation [Срок оценки: 1 month, 2 months, 3 months, 6 months after the operation]
• The attainment rate of systolic blood pressure reaching the standard in the outpatient clinic after the operation [Срок оценки: 1 month, 2 months, 3 months, 6 months after the operation]
• The change in systolic blood pressure measured in the outpatient clinic after the operation [Срок оценки: 1 month, 2 months, 3 months, 6 months after the operation]
• The average number of types of medications taken after the operation [Срок оценки: 1 month, 2 months, 3 months, 6 months after the operation]
• The incidence rate of complications of interventional treatment [Срок оценки: 1 month, 2 months, 3 months, 6 months after the operation]
• All-cause mortality rate [Срок оценки: 1 month, 2 months, 3 months, 6 months after the operation]
• Cardiovascular and cerebrovascular complications [Срок оценки: 1 month, 2 months, 3 months, 6 months after the operation]
• Renal complications [Срок оценки: 1 month, 2 months, 3 months, 6 months after the operation]
• The incidence rate of adverse events and serious adverse events [Срок оценки: 1 month, 2 months, 3 months, 6 months after the operation]
• The incidence rate of device defects. [Срок оценки: during the operation]

Критерии участия

Критерии включения

Males or females aged 18 years old or above and 65 years old or below; Patients with essential hypertension; Patients who have been stably taking 2 or more antihypertensive drugs at conventional doses continuously for at least 4 weeks before enrollment, and whose blood pressure meets the following conditions: (1) The systolic blood pressure measured in the outpatient clinic is ≥150 mmHg and ≤180 mmHg, and the diastolic blood pressure measured in the outpatient clinic is ≥90 mmHg; (2) The systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) is between 135 mmHg and 170 mmHg; The course of hypertension is more than 6 months; The diameter of the renal artery evaluated by renal artery CTA is ≥3 mm and the length is ≥20 mm; The patient or his/her legal representative signs a written informed consent form approved by the ethics committee before screening;

Критерии исключения

Complicated with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined as plasma Hb1Ac ≥ 10.0%); Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²; Previous implantation of an implantable cardioverter-defibrillator (ICD) or a pacemaker; History of myocardial infarction, syncope, intracerebral hemorrhage or cerebral infarction within 6 months before signing the informed consent form; Severe valvular heart stenosis; Any factors that may interfere with blood pressure measurement under any circumstances (for example, the patient has severe peripheral vascular disease, abdominal aortic aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia, severe anemia); Patients with sleep apnea syndrome; Females who are pregnant or breastfeeding, or those who have a plan to conceive within the next year; Other serious organic diseases with an expected lifespan of less than 12 months; Participation in other clinical trials before screening and not yet completed;

Preoperative exclusion criteria based on CTA imaging:

a. Visual inspection shows that the diameter stenosis of the renal artery on either side > 50% or there is a renal artery aneurysm on either side; b. Previous history of renal artery interventional treatment; Other situations that the investigator deems unsuitable for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital） — Гуанчжоу

Идентификаторы

NCT: NCT06877234 · MW-2301-T-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗