Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan

NCT ID: NCT06491940

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-07-31

Brief Summary

Losartan, an angiotensin II receptor blocker, has already been established as a treatment for diabetic nephropathy due to its ability to reduce blood pressure and mitigate the progression of kidney damage. However, the addition of a diuretic like hydrochlorothiazide may offer synergistic benefits in reducing proteinuria by addressing both the underlying renal pathology and potential volume overload in these patients. The current study aims at determining and comparing the role of losartan alone vs hydrochlorothiazide plus losartan in reducing proteinuria in diabetic nephropathy patients.

Conditions

Proteinuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Losartan group

Patients will receive Losartan (LS) 50 mg per day.

Group Type: EXPERIMENTAL

Losartan

Intervention Type: DRUG

Patients will receives Losartan (LS) 50 mg per day.

Losartan + Hydrochlorothiazide

Patients will be given losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy.

Group Type: EXPERIMENTAL

Losartan + Hydrochlorothiazide

Intervention Type: DRUG

Patients will be given Losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy.

Interventions

Losartan

Patients will receives Losartan (LS) 50 mg per day.

Intervention Type: DRUG

Losartan + Hydrochlorothiazide

Patients will be given Losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients of both genders with ≥18 years of age.
• Presence of proteinuria/albuminuria at time of screening.
• Creatinine clearance of 30 mL/min or higher.

Exclusion Criteria

• A systolic blood pressure of 180 mm Hg or higher, a diastolic blood pressure of 110 mm Hg or higher.
• Presence of a second primary renal disease in addition to diabetic nephropathy.
• Patients with type 1 diabetes.
• A history of a cardiovascular or cerebrovascular event within 3 months before inclusion.
• Serum potassium of 6.0 mmol/L or higher.
• Transplantation or immunosuppressive treatment.
• Contraindication for the use of losartan or hydrochlorothiazide.
• Pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RESnTEC, Institute of Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical department, Bahawal Victoria Hospital

Bahawalpur, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Muhammad Wasim Zahid

Role: CONTACT

drwasimzahid@gmail.com

03336361025

Other Identifiers

LosartanBVH

Identifier Type: -

Identifier Source: org_study_id