Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients

NCT07853625 | Not Yet Recruiting

• 1 other identifier: Exp144
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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)\[cite: 2\].

Conditions

Hypertension; Left Ventricular Diastolic Dysfunction; Essential (Primary) Hypertension

Outcome Measures

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

  Baseline and 6 months

Secondary Outcomes (2)

• Mean Change in Systolic Blood Pressure (SBP)

  Baseline, 8 weeks, and 6 months

• Echocardiographic Parameters of Diastolic Function

  Baseline, 8 weeks, and 6 months

Study Arms (2)

Group A: Sacubitril/Valsartan

EXPERIMENTAL

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.

Other: Sacubitril / Valsartan

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.

Other: Valsartan

Interventions

Sacubitril / Valsartan OTHER

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.

Group A: Sacubitril/Valsartan

Valsartan OTHER

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.

Group B: Valsartan

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Hypertension; Ventricular Dysfunction, Left; Essential Hypertension

Interventions

sacubitril and valsartan sodium hydrate drug combination; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: A prospective, randomized, open-label, parallel-group trial (1:1 allocation ratio) comparing Sacubitril/Valsartan versus Valsartan monotherapy in hypertensive patients with preserved ejection fraction and left atrial enlargement.

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share