Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism
The goal of this study is to compare the efficacy and safety of finerenone versus spironolactone in the treatment of hypertension due to primary aldosteronism.
It will be a randomized, double-blind, active-controlled, parallel-group clinical trial conducted at the Endocrine Hypertension Clinic, Department of Endocrinology, BSMMU. A total of 104 adult patients with confirmed primary aldosteronism will be enrolled and randomized equally to receive either finerenone (10-40 mg/day) or spironolactone (25-100mg/day) for 48 weeks. Study drugs will be titrated to achieve target blood pressure (<140/90mmHg) and unsuppressed plasma renin concentration (>15 mU/L). The primary efficacy outcome will be the time and daily dose required to attain this composite endpoint. Secondary outcomes include changes in clinic and ambulatory blood pressure, plasma aldosterone and renin levels, renal function (eGFR), urinary albumin excretion, left ventricular mass index, and quality of life. Safety outcomes will include adverse events, particularly hyperkalaemia and deterioration of renal function.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Sharmin Jahan, PhD
- 电话号码:+8801731061056
- 邮箱:sharminendo@bsmmu.edu.bd
学习地点
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Dhaka、孟加拉国、1000
- 招聘中
- Endocrine HTN Clinic
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接触:
- Sharmin Jahan, PhD
- 电话号码:+8801731061056
- 邮箱:sharminendo@bsmmmu.edu.bd
-
首席研究员:
- Sharmin Jahan, PhD
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age >18 years.
- History of hypertension (blood pressure >140/90 mm Hg), both newly detected and already established patients.
- Diagnosed case of primary aldosteronism (PA) based on a screening test (increased aldosterone renin ration (ARR) >70pmol/L) and confirmed by saline suppression test (post-saline PAC >170pmol/L, where PAC measured by immunoassay).
- Serum potassium ≥2.5 mmol/L.
Exclusion Criteria:
- Uncontrolled hypertension (>180/120 mm Hg).
- Lateralized PA patients (aldosterone producing adenoma or unilateral hyperplasia) who want to undergo adrenalectomy or having aldosterone producing carcinoma.
- Participants already with mineralocorticoid receptor antagonist treatment.
- Patients receiving medications confounding PAC or PRC (glucocorticoids, sodium glucose co-transporter 2 inhibitors (SGLT-2i) or systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, clarithromycin, rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz) that cannot be discontinued 14 days prior to randomization or for the duration of treatment period.
- Abnormal renal function test: eGFR <60 ml/min-1.73m2.
- Serum potassium level >5 mmol/L.
- Recent cardiovascular events like acute myocardial ischemia, heart failure with hospitalization, stroke or transient ischemic attack ≤3 months before the screening visit.
- Uncontrolled DM (HbA1C >12%)
- Hepatic insufficiency (Child-Pugh C)
- Addison's disease
- Pregnant and lactating women. Women with child bearing potential must agree to use adequate contraception during and until 2 month of the end of study period.
- Patient with other form of secondary HTN (e.g. renovascular HTN, Cushing syndrome, pheochromocytoma, coarctation of aorta etc.)
- Known hypersensitivity to the study drugs.
- Patients unwilling to participate in this study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Finerenone
Tab. Finerenone 10-40mg daily
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All participants in Finerenone group will get Tab.
Finerenone started at 10mg daily and titrated upto 40mg daily
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有源比较器:Spironolactone
Tab. Spironolactone 25-100mg daily
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All participants in Finerenone group will get Tab.
Finerenone started at 10mg daily and titrated upto 40mg daily
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dose of Finerenone
大体时间:12 month
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daily dose of finerenone required for attainment of composite endpoints of target blood pressure (<140/90 mmHg) and unsuppressed plasma renin concentration (>15 mU/L) from baseline in participants with PA
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12 month
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Time required
大体时间:12 month
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Time required for attainment of composite endpoints of target blood pressure (<140/90mmHg) and unsuppressed plasma renin concentration (>15 mU/L) from baseline in participants with PA
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12 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Systolic and Diastolic Blood Pressure
大体时间:12 month
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Change in mean clinic systolic and diastolic blood pressure from baseline to the end of 48 weeks treatment period.
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12 month
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Change in Blood pressure in ABPM
大体时间:12 month
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Change in mean systolic and diastolic blood pressure on ambulatory blood pressure monitoring (ABPM).
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12 month
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合作者和调查者
调查人员
- 首席研究员:Sharmin Jahan, PhD、Professor
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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