Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan

NCT06491940 | Not Yet Recruiting

• 1 other identifier: LosartanBVH
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reduction of proteinuria

  Efficacy will be labeled yes if reduction of proteinuria/albuminuria from the value before commencing treatment will be observed.

  4 months

Study Arms (2)

Losartan group

EXPERIMENTAL

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

Drug: Losartan

Losartan + Hydrochlorothiazide

EXPERIMENTAL

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

Drug: Losartan + Hydrochlorothiazide

Interventions

Losartan DRUG

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

Losartan group

Losartan + Hydrochlorothiazide DRUG

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

Losartan + Hydrochlorothiazide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Serum potassium of 6.0 mmol/L or higher.
• Transplantation or immunosuppressive treatment.
• Contraindication for the use of losartan or hydrochlorothiazide.
• Pregnancy or lactation.

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

Medical department, Bahawal Victoria Hospital

Bahawalpur, Punjab Province, 06318, Pakistan

Location

MeSH Terms

Conditions

Proteinuria

Interventions

Losartan; hydrochlorothiazide, losartan drug combination

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Central Study Contacts

Muhammad Wasim Zahid

CONTACT

03336361025; drwasimzahid@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: August 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)