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].
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Aktiv komparator: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Change in Left Atrial Volume Index (LAVI)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Change in Systolic Blood Pressure (SBP)
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Hjärtsjukdom
- Ventrikulär dysfunktion
- Essentiell hypertoni
- Hypertoni
- Ventrikulär dysfunktion, vänster
- Aminosyror, peptider och proteiner
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Azoler
- Aminosyror
- Aminosyror, väsentliga
- Tetrazoler
- Valr
- Aminosyror, grenad kedja
- Valsartan
- SACUBITRIL OCH VALSARTAN NATIUM HYRATE DRUG COMBINATION
Andra studie-ID-nummer
- Exp144
Plan för individuella deltagardata (IPD)
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