Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism

Обзор

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.

Вмешательства

• Препарат Finerenone
  All participants in Finerenone group will get Tab. Finerenone started at 10mg daily and titrated upto 40mg daily

Первичные конечные точки

• Dose of Finerenone [Срок оценки: 12 month]
• Time required [Срок оценки: 12 month]

Вторичные конечные точки (2)

• Change in Systolic and Diastolic Blood Pressure [Срок оценки: 12 month]
• Change in Blood pressure in ABPM [Срок оценки: 12 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Bangladesh · 1 центр

• Endocrine HTN Clinic — Dhaka

Идентификаторы

NCT: NCT07688928 · PR-1418

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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