Using diuretics to manage volume overload in early chronic kidney disease
Association of Diuretics With Change in Extracellular Volume, Natriuretic Peptides, Symptoms, and Cardiovascular Outcomes in CKD
This study tests if diuretic medications can help veterans with early chronic kidney disease and high blood pressure feel better and improve their heart health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05171686 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of diuretic medications on patients with early stages of chronic kidney disease (CKD) and hypertension. It aims to determine if changes in extracellular volume, as measured by natriuretic peptides, correlate with improvements in symptoms and cardiovascular function. The study will involve 46 outpatients who will receive diuretic treatment and will be monitored for changes in their symptoms and cardiovascular parameters. The goal is to establish a link between diuretic use and improved health outcomes in veterans with CKD.
Who should consider this trial
Good fit: Ideal candidates are male or female veterans aged 18 and older with stages 1-3 chronic kidney disease and elevated blood pressure.
Not a fit: Patients with advanced chronic kidney disease (stages 4-5), those on dialysis, or kidney transplant recipients may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of cardiovascular risks in patients with early chronic kidney disease.
How similar studies have performed: Previous studies have shown that natriuretic peptides are associated with cardiovascular outcomes in CKD, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Lucile P Gregg, MD MS — Michael E. DeBakey VA Medical Center, Houston, TX
- Study coordinator: Lucile P Gregg, MD MS
- Email: lucile.gregg@va.gov
- Phone: (713) 440-4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.