Association of Diuretics With Change in Extracellular Volume, Natriuretic Peptides, Symptoms, and Cardiovascular Outcomes in CKD

Who is this study for? Patients with chronic kidney disease
What treatments are being studied? Diuretic augmentation
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Almost 15% of Americans have chronic kidney disease (CKD), with an even higher rate in Veterans due to common risk factors such as high blood pressure and diabetes. People with CKD have a high risk of cardiovascular (CV) diseases, such as heart attacks, heart failure, and strokes. Extra fluid in the body, called volume overload, may lead to CV disease in people with CKD. It is unknown if volume overload develops in the earliest stages of CKD, when treating it with common, inexpensive medicines called diuretics may improve long-term CV outcomes. This study will lay important groundwork to answer this question in Veterans with early CKD by comparing two ways to measure volume overload and studying the change in common symptoms like fatigue and short-term CV function after treatment with diuretic medicines.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 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.

Locations
United States
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
Contact Information
Primary
Lucile P Gregg, MD MS
lucile.gregg@va.gov
(713) 440-4400
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 46
Treatments
Experimental: Diuretic augmentation
The participant's blood pressure medication regimen will be altered to initiate a thiazide-type or loop diuretic in those not already prescribed a diuretic, or to increase the dose if one is already prescribed.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov