Evaluation and Exploration of the Safety and Efficacy of Superselective Adrenal Arterial Embolization in Patients With Essential Refractory Hypertension: A Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 24-hour mean systolic blood pressure
研究概览
简要总结
The subjects of this study were patients with essential refractory hypertension. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.
详细描述
The subjects of this study were patients with essential refractory hypertension. The study design was a single-center, open-label, self-controlled, single-arm, prospective study. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years, no gender restrictions;
- •Primary refractory hypertension: Taking three antihypertensive drugs, including a - diuretic, with an average office systolic blood pressure ≥150 mmHg measured three times;
- •Duration of hypertension greater than 6 months;
- •Standing plasma aldosterone and renin activity not below the lower limit of the unit's reference range;
- •Signed informed consent form.
排除标准
- •Morning cortisol level < 4.3 µg/dL; estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²; serum potassium level > 5.5 mmol/L;
- •Type 1 diabetes, uncontrolled hyperthyroidism, malignant arrhythmias, malignant tumors, decompensated heart failure, severe liver dysfunction, severe hematological diseases, severe obstructive sleep apnea syndrome, history of myocardial infarction, syncope, cerebral hemorrhage, or cerebral infarction within the past 3 months;
- •Pregnant women or those planning to conceive within the next year;
- •Presence of other severe organic diseases that would make the patient unable to tolerate superselective adrenal arterial embolization;
- •Adrenal mass with a diameter exceeding 2 cm;
- •Severe allergy to contrast agents;
- •Patients enrolled or planning to participate in other clinical studies that could impact the results of this study.
结局指标
主要结局
24-hour mean systolic blood pressure
时间窗: 8 weeks after SAAE
ambulatory blood pressure monitoring
次要结局
- Safety monitoring:Procedure-related complications(up to 8 weeks)
- Safety monitoring:Adrenal-related hormones(8 weeks after SAAE)
- Proportion of patients with non-refractory hypertension(8 weeks after SAAE)
- 24-hour mean diastolic blood pressure(8 weeks after SAAE)
- Safety monitoring:Kidney function(8 weeks after SAAE)
- Safety monitoring:Plasma electrolyte levels(8 weeks after SAAE)
研究者
Yifei Dong
Deputy Director of the Department of Cardiology
Second Affiliated Hospital of Nanchang University