RECRUITING

Neurovascular Transduction During Exercise in Chronic Kidney Disease

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

The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and to explore what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate). This study will also test whether or not regular exercise on a bicycle and/or treatment with 6R-BH4 (Kuvan) pills, or histidine and beta-alanine supplementation improves these measures during exercise. 6R-BH4 is currently FDA-approved for use in patients with certain forms of a disease called phenylketonuria, but it is not currently FDA approved for blood pressure or exercise capacity in people with CKD.

Official Title

Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease

Quick Facts

Study Start:2016-10
Study Completion:2024-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02947750

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 to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * severe CKD (eGFR\<15 cc/minute)
  2. * ongoing drug or alcohol abuse
  3. * diabetic neuropathy
  4. * any serious systemic disease that might influence survival
  5. * severe anemia with hgb level \<9 g/dL
  6. * clinical evidence of congestive heart failure or ejection fraction below 35%
  7. * symptomatic heart disease determined by prior electrocardiogram, stress test, and/or history
  8. * treatment with central alpha agonists (clonidine)
  9. * uncontrolled hypertension with BP greater than 170/100 mm Hg
  10. * low blood pressure with BP less than 100/50
  11. * pregnancy or plans to become pregnant
  12. * current treatment with monoamine oxidase (MAO) inhibitors
  13. * inability to exercise on a stationary bicycle

Contacts and Locations

Study Contact

Jeanie Park, MD
CONTACT
404-727-2525
jeanie.park@emory.edu

Principal Investigator

Joe Nocera, PhD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Atlanta VA Health Care System
Decatur, Georgia, 30033
United States

Collaborators and Investigators

Sponsor: Emory University

  • Joe Nocera, PhD, PRINCIPAL_INVESTIGATOR, Emory University

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 Date2016-10
Study Completion Date2024-10

Study Record Updates

Study Start Date2016-10
Study Completion Date2024-10

Terms related to this study

Keywords Provided by Researchers

  • Hypertension
  • Kidney Disorder
  • Nephrology
  • Physiology

Additional Relevant MeSH Terms

  • Renal Insufficiency, Chronic