Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients
Comparative Efficacy of Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients: A Randomized Controlled Trial
Hypertension is a leading global risk factor for cardiovascular disease and is frequently associated with left atrial and ventricular remodeling, leading to subclinical diastolic dysfunction[cite: 2]. Left Atrial Volume Index (LAVI) serves as a sensitive indicator of left ventricular diastolic dysfunction and a key predictor of adverse cardiovascular outcomes, including atrial fibrillation, stroke, and heart failure with preserved ejection fraction (HFpEF)[cite: 2]. Reversing or preventing left atrial enlargement is critical to improving long-term prognosis in hypertensive patients[cite: 2].
While sacubitril/valsartan (an angiotensin receptor-neprilysin inhibitor, ARNI) has demonstrated significant clinical benefits in heart failure, limited data exist regarding its comparative efficacy against valsartan alone in reversing left atrial remodeling in hypertensive patients with preserved ejection fraction (LVEF >50%)[cite: 2].
This randomized controlled trial aims to evaluate and compare the efficacy of sacubitril/valsartan versus valsartan monotherapy in reducing LAVI and improving blood pressure control over a 6-month treatment period in hypertensive patients with preserved ejection fraction and enlarged left atrium (LAVI >34 mL/m²)[cite: 2].
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients aged 40 to 65 years.
- Both male and female patients.
- Diagnosed with hypertension based on a self-reported history of hypertension with anti-hypertensive medication use for at least 4 weeks and a sitting systolic blood pressure ≥ 150 mmHg at presentation.
- Left ventricular ejection fraction (LVEF) > 50% assessed on echocardiography.
- Left atrial volume index (LAVI) > 34 mL/m² assessed on echocardiography.
Exclusion Criteria:
- Uncontrolled hypertension presenting with systolic blood pressure > 180 mmHg.
- Secondary hypertension (e.g., secondary to renal artery stenosis, end-stage renal disease, pheochromocytoma, or primary hyperaldosteronism).
- Hyperkalemia (serum potassium level > 5.5 mmol/L).
- History of chronic kidney disease (eGFR < 60 mL/min).
- Known history of hypersensitivity to sacubitril, valsartan, or related drug classes.
- Pregnant or lactating females.
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group A: Sacubitril/Valsartan
Participants receive Sacubitril/Valsartan 100 mg orally once daily for 8 weeks. The dose is titrated to 200 mg orally once daily if target blood pressure is not achieved at 8 weeks, with treatment continuing for a total duration of 6 months. |
Sacubitril/Valsartan administered orally once daily at an initial dose of 100 mg for 8 weeks, titrated to 200 mg once daily if target blood pressure is not met, for a total of 6 months. |
|
アクティブコンパレータ：Group B: Valsartan
Participants receive Valsartan 80 mg orally once daily for 8 weeks. The dose is titrated to 160 mg orally once daily if target blood pressure is not achieved at 8 weeks, with treatment continuing for a total duration of 6 months. |
Valsartan administered orally once daily at an initial dose of 80 mg for 8 weeks, titrated to 160 mg once daily if target blood pressure is not met, for a total of 6 months. |
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 |
|---|---|---|
|
Mean Change in Left Atrial Volume Index (LAVI)
時間枠：Baseline and 6 months
|
Change in Left Atrial Volume Index (LAVI) measured in mL/m² from baseline to 6 months . Left atrial volume is measured using transthoracic echocardiography (apical 4-chamber and 2-chamber views at end-systole) and normalized to body surface area calculated via the Du-Bois formula |
Baseline and 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change in Systolic Blood Pressure (SBP)
時間枠：Baseline, 8 weeks, and 6 months
|
Change in sitting systolic blood pressure (mmHg) measured using a standard blood pressure apparatus |
Baseline, 8 weeks, and 6 months
|
|
Echocardiographic Parameters of Diastolic Function
時間枠：Baseline, 8 weeks, and 6 months
|
Mean changes in parameters of diastolic function evaluated via echocardiography, including E/A ratio, E/e' ratio, deceleration time (DT in ms), and peak early diastolic mitral annular velocity (e' in cm/sec). |
Baseline, 8 weeks, and 6 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Exp144
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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