Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorUniversity of Health Sciences Lahore
About this 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)\[cite: 2\].
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Sacubitril / Valsartan
Other interventionSacubitril/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.
Valsartan
Other interventionValsartan 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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Group A: Sacubitril/ValsartanExperimental treatment 1 intervention
Group B: Group B: ValsartanActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Change in Left Atrial Volume Index (LAVI)
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
Time frame
Baseline and 6 monthsSecondary outcomes
1
Mean Change in Systolic Blood Pressure (SBP)
Change in sitting systolic blood pressure (mmHg) measured using a standard blood pressure apparatus
Time frame
Baseline, 8 weeks, and 6 months2
Echocardiographic Parameters of Diastolic Function
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).
Time frame
Baseline, 8 weeks, and 6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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