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Набор скоро начнётся NCT06783296

Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension

Без фазы С лечением Hypertension Renal Denervation Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Renal Denervation, Renal Angiography.
Кому может быть актуально
Состояния в реестре: Hypertension, Renal Denervation Therapy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension: A Multicenter, Double-Blind, Randomized, Sham-Controlled Clinical Trial

Обзор

This study aims to evaluate the efficacy and safety of renal denervation (RDN) in patients with isolated diastolic hypertension (IDH). The randomized, double-blind, sham-controlled, multicenter clinical trial will recruit 124 participants (62 in the treatment group and 62 in the sham control group) to assess changes in mean 24-hour ambulatory diastolic blood pressure over a 6-month follow-up period. The study is expected to provide evidence for the use of RDN as a treatment for IDH.

Вмешательства

  • Процедура Renal Denervation
    Renal denervation (RDN) was performed using radiofrequency ablation in the cardiac catheterization laboratory equipped with a digital subtraction angiography (DSA) system. Under intravenous anesthesia, femoral artery access was obtained and a renal denervation sheath was advanced. An ablation catheter was then introduced to both renal arteries, and ablations were applied across four quadrants to achieve circumferential denervation. Throughout the procedure, vital signs were continuously monitore
  • Процедура Renal Angiography
    Renal angiography was performed under intravenous anesthesia via femoral artery access, and the procedure lasted approximately 1 hour to simulate the duration of active RDN.

Первичные конечные точки

  • Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up [Срок оценки: 6 months after intervention]
Вторичные конечные точки (6)
  • The proportion of patients achieving hypertension control without antihypertensive medication at the 6-month follow-up [Срок оценки: 6 months after intervention]
  • Changes in 24-hour ambulatory systolic/diastolic blood pressure (daytime, nighttime, and overall periods) at the 6-month follow-up [Срок оценки: 6 months after intervention]
  • Changes in office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up [Срок оценки: 3/6/12 months after intervention]
  • Changes in home/office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up [Срок оценки: 3/612 months after intervention]
  • The incidence of procedure-related adverse events and complications at 6-month follow-up [Срок оценки: 6 months after intervention]
  • The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and all-cause mortality at 6-month follow-up [Срок оценки: 6 months after intervention]

Критерии участия

Критерии включения

  • Age ≥18 years, with no restriction on sex or ethnicity;
  • Diagnosis of primary hypertension, with no prior use of antihypertensive medication, and in the untreated state presenting with office systolic blood pressure (SBP) <140 mmHg and diastolic blood pressure (DBP) ≥90 mmHg, as well as 24-hour ambulatory blood pressure monitoring (ABPM) showing SBP <130 mmHg and DBP ≥80 mmHg;
  • Willingness to participate and provision of written informed consent.

Критерии исключения

  • DBP ≥110 mmHg;
  • Secondary hypertension;
  • Requirement for antihypertensive or blood pressure-lowering medications due to comorbid conditions (e.g., SGLT2 inhibitors, GLP-1 receptor agonists);
  • Cardiac arrhythmias interfering with blood pressure measurement (e.g., atrial fibrillation);
  • Contraindications to RDN, including renal transplantation, renal insufficiency (eGFR <45 mL/min/1.73 m²), renal artery anatomy unsuitable for the procedure (inability to access the renal vasculature; renal artery diameter <4 mm or length <20 mm; hemodynamically or anatomically significant renal artery abnormalities or stenosis; prior coronary or renal artery interventions including angioplasty or stenting), and severe hepatic impairment;
  • Contraindications to interventional procedures such as coagulopathy;
  • Pregnancy, planning pregnancy, or breastfeeding;
  • Life expectancy <1 year;
  • Participation in another clinical trial.

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 · 1 центр
  • Department of Cardiology, Shanghai Tenth People's Hospital — Шанхай

Идентификаторы

NCT: NCT06783296 · STOP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗