A Double-blind, Randomized Controlled Study of Finerenone vs. Spironolactone in Hypertensive Patients With Primary Aldosteronism
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The change of 24-hour ambulatory systolic blood pressure from the baseline level.
研究概览
简要总结
To study the efficacy and safety of finerenone vs. spironolactone in patients with primary aldosteronism
详细描述
- Study design: This is a multi-center, double-blind, randomized, non-inferiority trial of finerenone vs. spironolactone in hypertensive patients with primary aldosteronism (PA). All patients will be randomized into finerenone group (Intervention group) and spironolactone group (Control group).
- Objective: To compare the antihypertensive effects and Correction of hypokalemia in patients with PA.
- Medicine: Finerenone (10mg tablet) and the matching placebo; Spironolactone (20mg tablet) and the matching placebo.
- Study population: Men or women aged from18 years to 75 years old, with history of hypertension, Clinic DBP <110 mmHg, SBP <180 mmHg without any antihypertensive drugs for 2 weeks, were diagnosed PA and confirmed by captopril inhibition test or Saline infusion test. At the end of induction, Serum potassium level ≥ 3 mmol/L but less than 5 mmol/L.
- Randomized and treatment: The initial dose of finerenone group is 10mg and spironolactone group is 20mg, respectively (week 0). For patients not meeting clinic blood pressure < 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finerenone or spironolactone should be increased one tablet at every visit (week 2, week 4). The whole treatment period was 8 weeks.
- Follow up: After the induction period of two weeks and meeting the inclusion criteria, the patients with primary aldosteronism were randomized in an equal ratio to receive finerenone 10mg once daily. Patients received the initial dose (10mg, week 0) of drug for the first two weeks of randomized treatments period. Thereafter, the dose of finernone would not be changed for the adequate blood pressure (BP) control and the normal serum potassium. For patients not meeting BP < 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finerenone would be increased to 20mg once daily for the second 2 weeks later (week 2) and 30 mg 4 weeks later (week 4), respectively. The whole treatment period was 8 weeks. if blood pressure > 160/110 mmHg during the clinical trial, amlodipine 5 mg once was added. At every visit, the clinic and ambulatory blood pressure will be measured. The levels of serum potassium, creatinine, renin, aldosterone will be examined. The urinary microalbumin creatinine ratio will be also examined.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Department of Hypertension, Ruijin Hospital, Shanghai, China.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old.
- •History of hypertension, Clinic DBP <110 mmHg, SBP <180 mmHg without any antihypertensive drugs for 2 weeks.
- •Primary Aldosteronism diagnosed and confirmed by captopril inhibition test or Saline infusion test.
- •At the end of induction, Serum potassium level ≥ 3 mmol/L but less than 5 mmol/L.
- •Signed the informed consent
排除标准
- •Other kinds of secondary hypertension
- •Obesity with BMI>30kg/m²（BMI= kg/㎡）
- •Serum potassium > 5.5 mmol/L
- •Serious hypertension（msSBP≥180mmHg, and/or msDBP≥110mmHg）
- •Abnormal renal function: serum creatinine ≥ 2 × ULN or eGFR < 25 ml/(min * 1.73㎡);
- •Abnormal liver function: ALT and AST ≥ 2 × ULN；
- •Cardiac insufficiency, acute myocardial infarction, stroke or other acute cardiovascular events within 6 months;
- •Take spironolactone, guanethidine or reserpine 30 days before enrollment;
- •Known or suspected tumor; Other autoimmune diseases, uncontrolled infectious diseases, serious respiratory, blood and nervous system diseases;
- •There is a pregnancy plan in pregnancy or 3 months before and after treatment. Breast-feeding women;
- •Those who have mental illness, alcohol or drug abuse and cannot cooperate with treatment.
- •Be allergic to the study drugs
- •Without Signed the informed consent
- •Anticipating another clinical trial
研究组 & 干预措施
Finerenone group
After the induction period of two weeks, the patients with primary aldosteronism were randomized in an equal ratio to receive finerenone 10mg once daily. Patients received the initial dose (10mg, week 0) of drug for the first two weeks of randomized treatments period. Thereafter, the dose of finerenone would not be changed for the adequate blood pressure (BP) control and the normal serum potassium. For patients not meeting BP < 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finerenone would be increased to 20mg once daily for the second 2 weeks later (week 2) and 30 mg 4 weeks later (week 4), respectively. The whole treatment period was 8 weeks. if blood pressure > 160/110 mmHg during the clinical trial, amlodipine 5 mg once was added.
干预措施: Finerenone (Drug)
Spironolactone group
After the induction period of two weeks, the patients with primary aldosteronism were randomized in an equal ratio to receive spironolactone 20mg once daily. Patients received the initial dose (20mg, week 0) of drug for the first two weeks of randomized treatments period. Thereafter, the dose of spironolactone would not be changed for the adequate blood pressure (BP) control and the normal serum potassium. For patients not meeting BP < 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finernone would be increased to 40mg once daily for the second 2 weeks later (week 2) and 60 mg 4 weeks later (week 4), respectively. the whole treatment period was 8 weeks. if blood pressure > 160/110 mmHg during the clinical trial, amlodipine 5 mg once was added.
干预措施: Spironolactone (Drug)
结局指标
主要结局
The change of 24-hour ambulatory systolic blood pressure from the baseline level.
时间窗: 8 weeks
24-hour ambulatory systolic blood pressure
The proportion of patients with normal serum potassium level.
时间窗: 8 weeks
serum potassium level
次要结局
- The changes of plasma renin and aldosterone from the baseline levels.(8 weeks)
- The change of estimate glomerular filtration rate from the baseline level.(8 weeks)
- The change of other components of 24-hour ambulatory blood pressure from the baseline level.(8 weeks)
- The change of urinary microalbumin creatinine ratio (ACR) from the baseline level.(8 weeks)
- The change of clinic systolic and diastolic blood pressure from the baseline level.(8 weeks)
研究者
Ji-Guang Wang
Director of the Shanghai Institute of Hypertension, Director of the Department of Hypertension
Shanghai Jiao Tong University School of Medicine