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

September 26, 2026 updated by: Saad Jamal, University of Health Sciences Lahore

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].

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Sacubitril / Valsartan

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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Left Atrial Volume Index (LAVI)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Systolic Blood Pressure (SBP)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

September 26, 2026

First Submitted That Met QC Criteria

September 26, 2026

First Posted (Actual)

October 2, 2026

Study Record Updates

Last Update Posted (Actual)

October 2, 2026

Last Update Submitted That Met QC Criteria

September 26, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exp144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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