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NCT07853625
Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients
Conditions: Hypertension, Left Ventricular Diastolic Dysfunction, Essential (Primary) Hypertension
Sex: All
Ages: 40 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 102
Sponsor: University of Health Sciences Lahore
Summary
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)\[cite: 2\].
Eligibility Criteria
Inclusion Criteria:
1. Patients aged 40 to 65 years.
2. Both male and female patients.
3. 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.
4. Left ventricular ejection fraction (LVEF) \> 50% assessed on echocardiography.
5. Left atrial volume index (LAVI) \> 34 mL/m² assessed on echocardiography.
Exclusion Criteria:
1. Uncontrolled hypertension presenting with systolic blood pressure \> 180 mmHg.
2. Secondary hypertension (e.g., secondary to renal artery stenosis, end-stage renal disease, pheochromocytoma, or primary hyperaldosteronism).
3. Hyperkalemia (serum potassium level \> 5.5 mmol/L).
4. History of chronic kidney disease (eGFR \< 60 mL/min).
5. Known history of hypersensitivity to sacubitril, valsartan, or related drug classes.
6. Pregnant or lactating females.
Source: ClinicalTrials.gov (NCT07853625). StuddyBuddy aggregates publicly available trial information.