Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Dose of Finerenone
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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-1.73m
- •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
结局指标
主要结局
Dose of Finerenone
时间窗: 12 month
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
Time required
时间窗: 12 month
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
次要结局
- Change in Systolic and Diastolic Blood Pressure(12 month)
- Change in Blood pressure in ABPM(12 month)
研究者
Sharmin Jahan
Professor Dr. Sharmin Jahan
Bangladesh Medical University