NCT07853625Not yet recruiting
Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients
Comparative Efficacy of Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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)\[cite: 2\].
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 26 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- University of Health Sciences Lahore
- Diseases
- High blood pressure
- NCT number
- NCT07853625
What you commit to
- Study type: Interventional
- Planned participants: 102
- From 1 Oct 2026 to the primary completion date, 30 Apr 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
- Known history of hypersensitivity to sacubitril, valsartan, or related drug classes.
Lab values
- Hyperkalemia (serum potassium level \> 5.5 mmol/L).
- History of chronic kidney disease (eGFR \< 60 mL/min).
Other
- Pregnant or lactating females.
Who the study is looking for
- 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.
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.