Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN

Korábbi kezelés

• 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 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.
• Currently participating in other clinical trials of drugs or medical devices.

Más betegség

• 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).
• 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).
• Acute or severe systemic infection.
• Having obvious symptoms of active peptic ulcer (such as abdominal pain, nausea, vomiting, regurgitation, etc.).
• Having obvious bleeding tendency and hematological diseases.

Laborértékek

• Glomerular filtration rate (eGFR) < 45 mL/min/1.73m² (MDRD formula).

Egyéb

• Hyperthyroidism or hypothyroidism.
• Requiring mechanical ventilation for assisted breathing (except for nocturnal respiratory support for treating sleep apnea).
• Having an implantable cardioverter - defibrillator (ICD) or pacemaker.
• Pregnant, lactating women, or women planning to become pregnant during the study period.
• Other reasons that the investigator deems inappropriate for participation in this study

• 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