Diuretics and Volume Overload in Early CKD

• Status: Withdrawn
• Trial end date: 2020-08-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Diuretics

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.

• 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.

• Rationale: The investigators' unpublished preliminary data show that blood pressure correlates with both BNP and NT-pro-BNP more strongly in those with CKD than those without CKD. Thus, selecting hypertensive individuals is more likely to identify those with elevated natriuretic peptides in the CKD group.

• Furthermore, starting or increasing a diuretic medication is part of standard of care to treat blood pressures >140/90 mmHg, so the study intervention will be consistent with appropriate care for the Veteran and avoid hypotension.

• 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 mg/dL 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.

• Presence of metal prostheses.