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Effectiveness of Valsartan Alone vs Combination Therapy in Hypertensive Heart Disease

NCT07544888 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Shaikh Zayed Hospital, Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07544888 on ClinicalTrials.gov