ClinConnect ClinConnect Logo
Search / Trial NCT05171686

Diuretics and Volume Overload in Early CKD

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Dec 16, 2021

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Diuretic Chronic Kidney Disease Hypertension Extracellular Volume Natriuretic Peptides

ClinConnect Summary

This clinical trial is studying how extra fluid in the body, known as volume overload, affects people with early stages of chronic kidney disease (CKD) and whether using common medications called diuretics can help improve heart health. The focus is on Veterans, who often have CKD due to conditions like high blood pressure and diabetes. The research aims to see if volume overload is a problem in the early stages of CKD and how treating it might change symptoms such as tiredness or heart function.

To participate in this trial, you must be a male or female Veteran aged 18 or older with CKD stages 1, 2, or 3, and have high blood pressure. You will be asked to measure your symptoms and heart health before and after taking diuretic medications. If you have more severe CKD (stages 4-5), are on dialysis, or have certain heart or liver conditions, you may not be eligible. This study is important as it could help find better ways to manage heart health in those with early CKD, potentially leading to better long-term outcomes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male or female Veterans age 18 years or older. There will be no upper age limit.
  • The presence of CKD stages 1, 2, or 3, as defined below by Kidney Disease Improving Global Outcomes guidelines, for a period of at least 3 months.
  • Stage 1: eGFR 90 mL/min/1.73 m2 and spot urine albumin-to-creatinine ratio 30 mg/g.
  • Stage 2: eGFR 60-89 mL/min/1.73 m2 and spot urine albumin-to-creatinine ratio 30 mg/g.
  • Stage 3: eGFR 30-59 mL/min/1.73 m2.
  • Measured blood pressure either \>140 mmHg systolic or \>90 mmHg diastolic at the two most recent clinic visits.
  • Able to understand and sign informed consent after the nature of the study has been fully explained.
  • Exclusion Criteria:
  • Unable to understand or provide informed consent.
  • Unwilling or unable to participate in the protocol or comply with any of its components.
  • CKD stages 4-5, defined as eGFR \<30 mL/min/1.73 m2.
  • Receiving chronic hemodialysis or peritoneal dialysis.
  • Recipient of a kidney transplant.
  • Serum potassium \<3.5 mEq/L at baseline.
  • Known left ventricular ejection fraction \<40% on visual estimate based on chart review of available echocardiogram data.
  • Known hepatic cirrhosis.
  • Major limb amputation.
  • Known pregnancy.
  • Presence of a pacemaker or defibrillator.

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Houston, Texas, United States

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Lucile P Gregg, MD MS

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials