NCT06783296尚未招募不适用
Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension: A Multicenter, Double-Blind, Randomized, Sham-Controlled Clinical Trial
Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2026年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Renal Denervation Group
Experimental
干预措施: Renal Denervation (Procedure)
Renal Denervation Group
Experimental
干预措施: Renal Angiography (Procedure)
Sham Control Group
Sham Comparator
干预措施: Renal Angiography (Procedure)
结局指标
主要结局
Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up
时间窗: 6 months after intervention
次要结局
- Change in home blood pressure monitoring(3 months after intervention)
- control rate(6 months after intervention)
- The proportion of patients achieving hypertension control without antihypertensive medication at the 6-month follow-up(6 months after intervention)
- Changes in 24-hour ambulatory systolic/diastolic blood pressure (daytime, nighttime, and overall periods) at the 6-month follow-up(6 months after intervention)
- Changes in office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up(3/6/12 months after intervention)
- Changes in home/office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up(3/612 months after intervention)
- The incidence of procedure-related adverse events and complications at 6-month follow-up(6 months after intervention)
- The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and all-cause mortality at 6-month follow-up(6 months after intervention)
研究者
Ya-Wei Xu
professor of Medicine
Shanghai 10th People's Hospital
研究点 (1)
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