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

(DOCK Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Lucile P Gregg, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lucile P Gregg, MD

Principal Investigator

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Eligibility Criteria

Inclusion Criteria

The presence of CKD stages 1, 2, or 3, as defined below by National Kidney Foundation 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.

Treatment Details

Interventions

• Diuretic (Diuretic)

Participant Groups

Group I: Diuretic initiation or augmentation Experimental Treatment 1 Intervention

Participants will either initiate or increase the dose of a loop or thiazide-type diuretic

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine