Effectiveness of Valsartan Alone vs Combination Therapy in Hypertensive Heart Disease

NCT07544888 | Completed Phase 1

• 2 other identifiers: Shaikh Zayed Hospital LahoreNo grant or funding
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Heart Diseases; Hypertension

Outcome Measures

Primary Outcomes (1)

• Effectiveness

  It will be labelled as per Appendix-I as markedly effective, effective and ineffective. Both markedly effective and effective will be labelled as effective.

  At 8 weeks

Secondary Outcomes (6)

• Headache

  At 8 weeks

• Vertigo

  At 8 weeks

• Nausea

  At 8 weeks

• Vomiting

  At 8 weeks

• Dry Cough

  At 8 weeks

Study Arms (2)

Group A (Combination Therapy): Valsartan 80 mg + Hydrochlorothiazide 25 mg Daily

EXPERIMENTAL

Group A (Experimental Arm - Valsartan + Hydrochlorothiazide): Participants receive Valsartan 80 mg plus Hydrochlorothiazide 25 mg orally once daily for 8 weeks. Initial Hydrochlorothiazide dose is 6.5 mg/day, 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 (headache, vertigo, nausea, dry cough, edema) are monitored and managed per hospital protocol. This arm tests whether combination therapy is more effective than Valsartan alone in hypertensive heart disease.

Drug: Valsartan + Hydrochlorothiazide

Active Comparator Arm (Group B): Valsartan (80 mg) once daily (Monotherapy)

ACTIVE COMPARATOR

Group B (Active Comparator - Valsartan Alone): Participants receive Valsartan 80 mg orally once daily for 8 weeks. Clinical effectiveness and safety are monitored using the same criteria as Group A. This arm represents standard-of-care therapy and serves as a comparator to evaluate the incremental benefit of combination therapy.

Drug: Valsartan + Hydrochlorothiazide

Interventions

Valsartan + Hydrochlorothiazide DRUG

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.

Active Comparator Arm (Group B): Valsartan (80 mg) once daily (Monotherapy); Group A (Combination Therapy): Valsartan 80 mg + Hydrochlorothiazide 25 mg Daily

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaikh Zayed Hospital, Lahore: lead

Study Sites (1)

Department of Cardiology

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

• 1. Ismail TF, Frey S, Kaufmann BA, Winkel DJ, Boll DT, Zellweger MJ, et al. Hypertensive Heart Disease-The Imaging Perspective. J Clin Med 2023;12(9):3122-6.

  RESULT

MeSH Terms

Conditions

Heart Diseases; Hypertension

Interventions

Valsartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS-II, Post Graduate Resident

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: April 22, 2026
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)