[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658658":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":21,"armGroups":29,"interventions":42,"overallOfficials":21,"centralContacts":21,"locations":21,"responsibleParty":51,"collaborators":21,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":21,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":21,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":21,"overallStatus":76,"whyStopped":21,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":21},{"fullName":5,"class":6},"University of Health Sciences Lahore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Mean Change in Left Atrial Volume Index (LAVI)","Change in Left Atrial Volume Index (LAVI) measured in mL\u002Fm² 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",[14,18],{"measure":15,"description":16,"timeFrame":17},"Mean Change in Systolic Blood Pressure (SBP)","Change in sitting systolic blood pressure (mmHg) measured using a standard blood pressure apparatus","Baseline, 8 weeks, and 6 months",{"measure":19,"description":20,"timeFrame":17},"Echocardiographic Parameters of Diastolic Function","Mean changes in parameters of diastolic function evaluated via echocardiography, including E\u002FA ratio, E\u002Fe' ratio, deceleration time (DT in ms), and peak early diastolic mitral annular velocity (e' in cm\u002Fsec).",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","PARALLEL","A prospective, randomized, open-label, parallel-group trial (1:1 allocation ratio) comparing Sacubitril\u002FValsartan versus Valsartan monotherapy in hypertensive patients with preserved ejection fraction and left atrial enlargement.","TREATMENT",{"masking":28,"maskingDescription":21,"whoMasked":21},"NONE",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Group A: Sacubitril\u002FValsartan","EXPERIMENTAL","Participants receive Sacubitril\u002FValsartan 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.",[35],"Other: Sacubitril \u002F Valsartan",{"label":37,"type":38,"description":39,"interventionNames":40},"Group B: Valsartan","ACTIVE_COMPARATOR","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.",[41],"Other: Valsartan",[43,47],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":21},"Sacubitril \u002F Valsartan","Sacubitril\u002FValsartan 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.",[31],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":21},"Valsartan","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.",[37],{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Saad Jamal","Principle Investigator","100658658","sacubitrilvalsartan-versus-valsartan-alone-on-left-atrial-volume-index-in-hypertensive-patients-100658658",false,"NCT07853625","Sacubitril\u002FValsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients","Comparative Efficacy of Sacubitril\u002FValsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients aged 40 to 65 years.\n2. Both male and female patients.\n3. 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.\n4. Left ventricular ejection fraction (LVEF) \\> 50% assessed on echocardiography.\n5. Left atrial volume index (LAVI) \\> 34 mL\u002Fm² assessed on echocardiography.\n\nExclusion Criteria:\n\n1. Uncontrolled hypertension presenting with systolic blood pressure \\> 180 mmHg.\n2. Secondary hypertension (e.g., secondary to renal artery stenosis, end-stage renal disease, pheochromocytoma, or primary hyperaldosteronism).\n3. Hyperkalemia (serum potassium level \\> 5.5 mmol\u002FL).\n4. History of chronic kidney disease (eGFR \\\u003C 60 mL\u002Fmin).\n5. Known history of hypersensitivity to sacubitril, valsartan, or related drug classes.\n6. Pregnant or lactating females.","ALL","40 Years","65 Years",{"count":66,"type":67},102,"ESTIMATED","INTERVENTIONAL",[70],"NA","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\\].\n\nWhile sacubitril\u002Fvalsartan (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\\].\n\nThis randomized controlled trial aims to evaluate and compare the efficacy of sacubitril\u002Fvalsartan 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\u002Fm²)\\[cite: 2\\].",[73,74,75],"Hypertension","Left Ventricular Diastolic Dysfunction","Essential (Primary) Hypertension","NOT_YET_RECRUITING","2026-09-26",{"date":79,"type":80},"2026-10-02","ACTUAL",{"date":82,"type":67},"2026-10-01",{"date":84,"type":67},"2027-05-31",{"name":5,"class":6}]