COMPLETED

Diuretics and Volume Overload in Early CKD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-01
Study Completion:2025-10-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05171686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female Veterans age 18 years or older. There will be no upper age limit.
  2. * 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.
  3. * Stage 1: eGFR 90 mL/min/1.73 m2 and spot urine albumin-to-creatinine ratio 30 mg/g.
  4. * Stage 2: eGFR 60-89 mL/min/1.73 m2 and spot urine albumin-to-creatinine ratio 30 mg/g.
  5. * Stage 3: eGFR 30-59 mL/min/1.73 m2.
  6. * Measured blood pressure either \>140 mmHg systolic or \>90 mmHg diastolic at the two most recent clinic visits.
  7. * Able to understand and sign informed consent after the nature of the study has been fully explained.
  1. * Unable to understand or provide informed consent.
  2. * Unwilling or unable to participate in the protocol or comply with any of its components.
  3. * CKD stages 4-5, defined as eGFR \<30 mL/min/1.73 m2.
  4. * Receiving chronic hemodialysis or peritoneal dialysis.
  5. * Recipient of a kidney transplant.
  6. * Serum potassium \<3.5 mEq/L at baseline.
  7. * Known left ventricular ejection fraction \<40% on visual estimate based on chart review of available echocardiogram data.
  8. * Known hepatic cirrhosis.
  9. * Major limb amputation.
  10. * Known pregnancy.
  11. * Presence of a pacemaker or defibrillator.

Contacts and Locations

Principal Investigator

Lucile P Gregg, MD MS
PRINCIPAL_INVESTIGATOR
Michael E. DeBakey VA Medical Center, Houston, TX

Study Locations (Sites)

Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Lucile P Gregg, MD MS, PRINCIPAL_INVESTIGATOR, Michael E. DeBakey VA Medical Center, Houston, TX

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2025-10-02

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2025-10-02

Terms related to this study

Keywords Provided by Researchers

  • diuretic
  • chronic kidney disease
  • hypertension
  • extracellular volume
  • natriuretic peptides

Additional Relevant MeSH Terms

  • Chronic Kidney Disease
  • Hypertension