The Effect of Selective Adrenal Artery Embolization and Spironolactone on Ventricular Remodeling in Nondominant Lateral Secretory Primary Aldosteronism： A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- LVMI
研究概览
简要总结
The study aims to assess the effect of superselective adrenal arterial embolization on ventricular remodeling in primary aldosteronism without lateralized aldosterone secretion by comparing it with spironolactone therapy.
详细描述
After being informed about the study and potential risks,all patients giving written informedconsent will undergo a 2-week screening period to determine eligibility for study entry.Atweek 0,patients who meet the eligibility requirements will be randomized in a 1:1 ratio to Superselective adrenal arterial embolization group or spironolactone therapy group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age 18-60 years old, regardless of gender;
- •(2) Blood pressure conditions meet one of the following: 1) Office blood pressure ≥ 140/90mmHg; 2) Ambulatory blood pressure monitoring whole day blood pressure > 130/80 mmHg or daytime blood pressure > 135/85 mmHg;
- •(3) After strict drug elution, it met the diagnostic criteria of primary aldosteronism, and bilateral primary aldosteronism was confirmed by adrenal venous sampling;
- •(4) No surgical intent or contraindication to surgery and willing to undergo pharmacological treatment or percutaneous superselective adrenal artery embolization;
- •(5) The patient or his/her legal representative shall sign the written informed consent approved by the ethics committee before the screening.
排除标准
- •(1) Primary hypertension or secondary hypertension with other causes;
- •(2) A woman who is pregnant or lactating, or has a birth plan for the next year;
- •(3) There are serious organic diseases, especially liver and kidney dysfunction(eGFR<45 mL/min/1.73 m2);
- •(4) Severe allergy to contrast medium;
- •(5) Other serious organic diseases, life expectancy < 12 months;
- •(6) Adrenal CT showed adenoma.;
- •(7) Patients are enrolled or want to participate in other clinical studies. During the enrollment study, the results of this study will be affected.
研究组 & 干预措施
SAAE group
Subjects received super selective adrenal artery embolization treatment
干预措施: Super selective adrenal artery embolization (Other)
Spironolactone group
Subjects received spironolactone treatment
干预措施: Spironolactone (Drug)
结局指标
主要结局
LVMI
时间窗: 12 months after SAAE
Left ventricular mass index(LVMI)
次要结局
- ABPM(12 months after SAAE)
- PRA(12 months after SAAE)
- serum creatinine(12 months after SAAE)
- ARR(12 months after SAAE)
- Serum potassium(12 months after SAAE)
- LVH(12 months after SAAE)
- PAC(12 months after SAAE)
研究者
Yifei Dong
Professor
Second Affiliated Hospital of Nanchang University