Compare the Efficacy and Safety of Finerenone, a New Type of Mineralocorticoid Receptor Antagonist, and Spironolactone in the Treatment of Primary Aldosteronism: a Single-Center, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 主要终点
- Hypertension remission rate.
研究概览
简要总结
Primary aldosteronism (PA) is thought to be the most common secondary endocrine form of hypertension. Compared with patients with essential hypertension with similar blood pressure, patients with PA have significantly higher atrial fibrillation, myocardial infarction, heart failure, stroke, deterioration of renal function and all-cause mortality. Therefore, early and systematic implementation of effective surgical or medical treatment is essential to prevent or reverse the excess vascular events and mortality of these patients. The patients with bilateral PA were mainly treated with mineralocorticoid receptor antagonists (MRAs). The MRA spironolactone is effective at lowering BP and reversing the harmful metabolic consequences, but its use is limited by adverse effects such as gynaecomastia, mastodynia, menstrual abnormalities and impotence due to its agonist activity at the progesterone receptor and antagonist activity at the androgen receptor. Finerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. In this study, we will compare the efficacy, safety and tolerability of finerenone versus spironolactone in patients with hypertension associated with primary aldosteronism.
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
- •1.Age: 18-75 years old.
- •2.History of hypertension, DBP <120 mmHg, SBP <180 mmHg.
- •3.Serum potassium level ≥ 2.5 mmol/L.
- •4.Primary Aldosteronis diagnosed by increased aldosterone renin ratio (ARR) > 30 ng/dl: ng/ml/h, and serum aldosterone levels ≥15 ng / dl, and confirmed by captopril inhibition test.
排除标准
- •Abnormal renal function: serum creatinine ≥ 2 × ULN or eGFR ≤ 60 ml/(min * 1.73m2);
- •Abnormal liver function: ALT and AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × 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.
研究组 & 干预措施
Finerenone
干预措施: Finerenone (Drug)
Spironolactone
干预措施: Spironolactone (Drug)
结局指标
主要结局
Hypertension remission rate.
时间窗: 12 weeks.
The proportion of patients with blood pressure\<140/90 mmHg at 12 weeks.
次要结局
- The change of systolic and diastolic BP from the baseline level.(Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.)
- Change of serum potassium level(Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.)
- Changes of plasma renin activity and ARR.(Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.)
- Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events.(Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.)
- Proportion of patients with normal serum.(Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks.)