To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension

Официальное название

A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation System in the Treatment of Primary Hypertension

Обзор

This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension.

Подробное описание

This trial adopts a prospective, multicenter, randomized controlled design to validate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension. Subjects who signed the informed consent form will enter the screening phase and undergo a run-in period for 4-week of standardized medication regimen. Specifically, their current antihypertensive treatment will be uniformly replaced with a combination of an angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) (Valsartan/Amlodipine 80:5 mg) or a triple combination of ARB/CCB (Valsartan/Amlodipine 80:5 mg) plus a diuretic (Hydrochlorothiazide 12.5mg) . If the subject's office systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg during the run-in period, the investigator may adjust the medication and restart a run-in period of ≥28 days. Blood pressure will be re-evaluated, and subjects failed to meet the inclusion criteria after adjustment will be excluded.

Subjects meeting the inclusion criteria and not violating exclusion criteria will be randomized in a 2:1 ratio to either the treatment group or the control group. The treatment group will undergo intravascular ultrasound ablation therapy, while the control group will only undergo renal artery angiography. Both groups will maintain the standardized medication regimen for 6 months post-procedure (if a subject's office SBP exceeds 180 mmHg or drops below 110 mmHg in three consecutive measurements spaced 1 hour apart, the investigator may adjust the medication and record their blood pressure before the adjustment).

The primary efficacy endpoint is the change in 24-hour average ambulatory systolic blood pressure at 6 months post-procedure. Results will be analyzed using a superiority testing hypothesis to demonstrate that the treatment group achieves significantly greater reduction in 24-hour mean ambulatory systolic blood pressure compared to the control group at 6-month follow-up. During follow-up, office blood pressure, 24-hour ambulatory blood pressure, medication usage, safety events, and adverse events will be recorded for both groups.

Вмешательства

• Процедура Intravascular Ultrasound Ablation Therapy
  The single-use intravascular ultrasound ablation catheter is used in conjunction with the ultrasound ablation device to remove renal sympathetic nerves. Standardized medication regimen.
• Процедура Renal Artery Angiography
  Only undergo renal artery angiography. Standardized medication regimen.

Первичные конечные точки

• Change in 24-hour average ambulatory systolic blood pressure (SBP) [at 6 months post-procedure] [Срок оценки: From baseline to 6 months]

Вторичные конечные точки (8)

• Change in Daytime/Nighttime Average Ambulatory Systolic Blood Pressure (SBP) [Срок оценки: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Change in 24-Hour/Daytime/Nighttime Average Ambulatory Diastolic Blood Pressure (DBP) [Срок оценки: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Change in 24-Hour Average Ambulatory Systolic Blood Pressure (SBP) [Срок оценки: 1 Month and 2 Months Post-Procedure]
• Change in Office Systolic Blood Pressure [Срок оценки: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Change in Office Diastolic Blood Pressure [Срок оценки: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Achievement Rate of Target Office Systolic Blood Pressure [Срок оценки: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Composite Index of Antihypertensive Medication Use [Срок оценки: 1 Month, 2 Months, and 6 Months Post-Procedure]
• Proportion of Subjects with ≥5 mmHg Reduction in 24-Hour Average Ambulatory Systolic Blood Pressure [Срок оценки: 6 Months Post-Procedure]

Критерии участия

Критерии включения

• Aged ≥18 years and ≤75 years, regardless of gender.
• Documented history of primary hypertension.
• Stable use of at least two antihypertensive medications for a minimum of 4 consecutive weeks prior to randomization, specifically requiring a combination of an angiotensin II receptor blocker (ARB) and a calcium channel blocker (CCB) or a triple combination of ARB/CCB plus a diuretic agent . After at least 4 consecutive weeks of screening, blood pressure must meet the following criteria:

• Office systolic blood pressure (SBP) ≥150 mmHg and <180 mmHg;
• Office diastolic blood pressure (DBP) ≥90 mmHg;
• 24-hour ambulatory systolic blood pressure ≥135 mmHg and <170 mmHg.
• Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to comply with clinical follow-up.

Критерии исключения

• Unsuitable Renal Artery Anatomy for Treatment

• Main renal artery diameter <4 mm or length <20 mm.
• Accessory renal artery diameter ≥ 2 mm and <4 mm.
• Renal artery stenosis >50% in the main renal artery.
• Renal artery aneurysm, fibromuscular dysplasia, or severe calcification.
• Presence of a renal artery stent.
• Single kidney.
• Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m².
• Diagnosis of Type 1 Diabetes Mellitus.
• Orthostatic Hypotension.
• Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form.
• Suspected Secondary Hypertension.
• Respiratory Support:a) Requirement for long-term oxygen support or mechanical ventilation (excluding nocturnal respiratory support for sleep apnea).
• Prior Renal Artery Denervation Procedure.
• Life Expectancy <1 Year.
• Pregnancy, Lactation, or Plans to Become Pregnant Within 6 Months (for Females); Males Planning to Conceive Within 6 Months.
• Current Participation in Another Clinical Trial Without Completion of the Primary Endpoint.
• Allergy to Contrast Agents.
• Other Reasons Deemed by the Investigator to Make the Subject Unsuitable for Participation (e.g., Poor Compliance).

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 18 центров

• Beijing Anzhen hospital , Capital Medical University — Пекин
• China-Japan Friendship Hospital — Пекин
• Peking University First Hospital — Пекин
• Beijing Jishuitan Hospital Affiliated to Capital Medical University — Пекин
• Beijing Tsinghua Changgung Hospital — Пекин
• The Second Affiliated Hospital Chongqing Medical University — Чунцин
• The First Affiliated Hospital of Xiamen University — Xiamen
• The Second Hospital of Lanzhou University — Lanzhou
• … и ещё 10 центров

Идентификаторы

NCT: NCT07051811 · LPCTP-2021-004(CT)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗