Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: a Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups.
研究概览
简要总结
To study the efficacy and safety of finerenone in patients with primary aldosteronism
详细描述
This is a prospective and randomized study involving patients with primary aldosteronism(PA). All paticipants will be randomized into finerenone group(Intervention group) and spironolactone group(Control group) and to compare the antihypertensive effect in patients with PA.
If the self-measured blood pressure of patients at home continues to be greater than 140/90 mmHg at 2-4 weeks, spironolactone or finerenone should be increased to 40mg qd, and electrolytes should be reviewed at 2 weeks after dosed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the following criterion can be included in this study.
- •Patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up.
- •Patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required.
- •Aged between 18-70, male or female, with legal capacity.
- •eGFR≥60(ml/min/1.73 m2)
- •Patients with PA and substandard blood pressure (≥140/90mmHg) who didn't take any antihypertensive drugs or who had been using antihypertensive drugs other than MRA steadily for 2 weeks or more
排除标准
- •Patients with one of the following conditions will be excluded in this study:
- •To assess patients with poor compliance who had difficulty fully participating in the study, or who refused to sign written informed consent for the study
- •Patients with heart failure (New York Heart Association (NYHA) class III or IV), liver transaminase levels were more than 2 times higher than the upper limit of normal, estimated glomerulus filtration rate<30ml/min/m2
- •Patients with serum potassium > 5.0mmol/L without potassium supplementation
- •Patients with stroke or acute coronary syndrome within 3 months
- •Pregnant or lactating women
- •Patients currently receiving sex hormone or glucocorticoid therapy
- •Patients with a history of uncontrolled malignant tumor
- •Patients who took MRA within 2 weeks
研究组 & 干预措施
Patients with PA using finerenone
Patients with PA divided into this group need to take finerenone for 60 days (20mg qd)
干预措施: finerenone (Drug)
结局指标
主要结局
Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups.
时间窗: At baseline and 2 month of follow-up
Measured by ambulatory blood pressure monitoring
次要结局
- Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups.(At baseline and 2 month of follow-up)
- Compare the serum potassium elevation in the overall cohort between two groups.(At baseline and 2 month of follow-up)
研究者
Qifu Li
Professor.Qifu Li
Chongqing Medical University