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Not yet recruitingNCT07853625Updated Oct 2, 2026

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

An interventional study of Sacubitril / Valsartan and Valsartan in Hypertension, Left Ventricular Diastolic Dysfunction and Essential (Primary) Hypertension, sponsored by University of Health Sciences Lahore. Not yet recruiting. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Treatment

Updated Oct 2, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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].

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Conditions studied

  • Hypertension
  • Left Ventricular Diastolic Dysfunction
  • Essential (Primary) Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 102 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Health Sciences Lahore is the lead sponsor of 77 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherSacubitril / 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.

  • OtherValsartan

    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.

06

What researchers measure

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 months

Secondary 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 months

  2. 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 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07853625
Lead sponsor
University of Health Sciences Lahore
Responsible party
Saad Jamal (Principle Investigator, University of Health Sciences Lahore) — Principal investigator
First posted
Oct 2, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Oct 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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