HypertensionNCT07853625
Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients
A study testing Sacubitril / Valsartan and Valsartan in people with Hypertension and Left Ventricular Diastolic Dysfunction, run by University of Health Sciences Lahore.
Trial 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]. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypertension, Left Ventricular Diastolic Dysfunction, Essential (Primary) Hypertension
- What is being tested?
- Sacubitril / Valsartan and Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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].
- Being tested
- Sacubitril / Valsartan, Valsartan
- Medical subject headings
- Hypertension, Ventricular Dysfunction, Left, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril / ValsartanOther
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.
ValsartanOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6 months
Secondary outcomes (2)
Mean Change in Systolic Blood Pressure (SBP)
Change in sitting systolic blood pressure (mmHg) measured using a standard blood pressure apparatus
Measured: Baseline, 8 weeks, and 6 months
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).
Measured: Baseline, 8 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saad Jamal, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853625
- Sponsor's protocol ID
- Exp144
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No