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NCT07544888CompletedPhase 1

Effectiveness of Valsartan Alone vs Combination Therapy in Hypertensive Heart Disease

Comparison of Effectiveness of Combination of Valsartan and Hydrochlorothiazide Versus Valsartan Alone in the Treatment of Hypertensive Heart Disease

Source: ClinicalTrials.gov · Last updated 22 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
118 (actual)
First submitted
14 Mar 2026
Start date
1 Nov 2025
Primary completion date
1 Mar 2026
Lead sponsor
Shaikh Zayed Hospital, Lahore
NCT number
NCT07544888

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 118
  • From 1 Nov 2025 to the primary completion date, 1 Mar 2026
  • 1 site in 1 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

  • Patients with drug allergies or contraindications to the medications used in this study.
  • Patients attending emergency unit with hypertension, those with poor compatibility and compliance.
  • Patients with other endocrine diseases, those with coagulation dysfunction.
  • Patients with mental disorders, and patients whose health conditions will be complicated by infectious or immune diseases.

Who the study is looking for

  • Patients of both the genders diagnosed with hypertensive heart disease as per operational definition.
  • Age18-70 years

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Cardiology
Coordinator of this site? Confirm its status
LahorePakistanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.