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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sharmin Jahan, PhD
- 電話番号：+8801731061056
- メール：sharminendo@bsmmu.edu.bd
研究場所
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Dhaka、バングラデシュ、1000
- 募集
- Endocrine HTN Clinic
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コンタクト：
- Sharmin Jahan, PhD
- 電話番号：+8801731061056
- メール：sharminendo@bsmmmu.edu.bd
-
主任研究者：
- Sharmin Jahan, PhD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dose of Finerenone
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Systolic and Diastolic Blood Pressure
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Sharmin Jahan, PhD、Professor
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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