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Effectiveness of Valsartan Alone vs Combination Therapy in Hypertensive Heart Disease
Sponsor: Shaikh Zayed Hospital, Lahore
Summary
Hypertension is a major global health problem, affecting about 30% of people and up to two-thirds of those over 60 years. Its prevalence has increased significantly, with over one billion adults affected worldwide and expected to reach 1.56 billion by 2025, especially in developing countries where early diagnosis and treatment are limited. Long-term hypertension can lead to hypertensive heart disease (HHD), which includes left ventricular hypertrophy and increases the risk of stroke, heart attack, heart failure, and kidney disease. Diagnosis is based on clinical assessment along with ECG, echocardiography, and cardiac MRI. Management focuses on controlling blood pressure and preventing heart damage. Valsartan, an angiotensin receptor blocker, and hydrochlorothiazide, a thiazide diuretic, are commonly used treatments. Studies suggest that combining these drugs may be more effective than valsartan alone, with better outcomes and fewer side effects. However, local evidence in Pakistan is limited. This study aims to compare valsartan plus hydrochlorothiazide versus valsartan alone in patients with HHD. A randomized controlled trial will be conducted at Sheikh Zayed Hospital, Lahore, including 118 patients aged 18-70 years diagnosed with HHD. Participants will be divided into two groups: one receiving combination therapy and the other valsartan alone for eight weeks, with dose adjustments as needed. Effectiveness will be classified as effective or ineffective. Patient data, including age, gender, BMI, and disease duration, will be analyzed using SPSS version 26. Results will be compared using the chi-square test, with further analysis to control confounding factors. This study will help determine the better treatment option and support improved management of hypertension in Pakistan.
Official title: Comparison of Effectiveness of Combination of Valsartan and Hydrochlorothiazide Versus Valsartan Alone in the Treatment of Hypertensive Heart Disease
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2025-11-01
Completion Date
2026-03-01
Last Updated
2026-04-22
Healthy Volunteers
Yes
Conditions
Interventions
Valsartan + Hydrochlorothiazide
Group A (Experimental Arm - Valsartan + Hydrochlorothiazide): Participants receive Valsartan 80 mg plus Hydrochlorothiazide 25 mg orally once daily for 8 weeks. Hydrochlorothiazide starts at 6.5 mg/day and may be titrated to 13 mg/day based on response. Effectiveness is assessed via blood pressure reduction, ECG evidence of left ventricular hypertrophy, and symptom improvement. Adverse events such as headache, vertigo, nausea, dry cough, and edema are monitored and managed according to hospital protocol. This arm evaluates whether combination therapy provides superior outcomes compared to monotherapy. Group B (Active Comparator Arm - Valsartan Alone): Participants receive Valsartan 80 mg orally once daily for 8 weeks. Effectiveness and safety are monitored using the same criteria as Group A. This arm serves as the standard-of-care comparator to assess the added benefit of combination therapy.
Locations (1)
Department of Cardiology
Lahore, Punjab Province, Pakistan