RECRUITING

Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD

Conditions

Chronic Kidney Disease Exercise training Sodium bicarbonate Exercise pressor reflex

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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 goals of this project are to investigate the mechanisms and potential therapies related to exercise capacity in persons with chronic kidney disease (CKD).

Official Title

Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD

Quick Facts

Study Start:2022-11-11

Study Completion:2028-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05928936

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:40 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* patients with CKD (Stages III and IV), kidney transplant recipients with varying degrees of kidney function, or persons without kidney disease as matched study controls * sedentary and do not regularly exercise (defined as exercising \< 20 minutes twice per week) * CKD patients must have stable renal function (no greater than a decline of estimated glomerular filtration (eGFR) of 1 cc/min/1.73 m2 per month over the prior 6 months) and baseline serum bicarbonate 22-24 mmol/L * comorbid hypertension	* severe CKD (eGFR\<15 cc/min) * metabolic alkalosis * current treatment with bicarbonate * ongoing drug or alcohol abuse * diabetic neuropathy, autonomic dysfunction * any serious disease that might influence survival * anemia with hemoglobin \<10 g/dL * clinical evidence of heart failure * volume overload or ejection fraction below 45% * symptomatic heart disease by EKG, stress test, and/or history * treatment with central α-agonists (clonidine) * myocardial infarction or cerebrovascular accident within the past six months * uncontrolled hypertension (BP\>170/100 mm Hg) * low BP\<100/50 mm Hg * surgery within the past 3 months * pregnancy or plans to become pregnant * inability to exercise on a stationary bicycle * contraindication to temporary withdrawal of α- and β-blockers * peripheral arterial disease * class 3 obesity (BMI\>40) * hypo- or hyperkalemia (K\<3.5meq/L, K\>5.0 meq/L) * current use of immunosuppressive medications (including but not limited to steroids, cyclophosphamide, calcineurin inhibitors, mycophenolate, biologics, methotrexate, etc) * arteriovenous (AV) fistula/graft * any contraindication to MR scanning including cardiac pacemaker, cochlear implants, neurostimulators, implanted devices with metal, any metal in the body that could pose a hazard during scanning, history of claustrophobia

Inclusion Criteria

Exclusion Criteria

* patients with CKD (Stages III and IV), kidney transplant recipients with varying degrees of kidney function, or persons without kidney disease as matched study controls
* sedentary and do not regularly exercise (defined as exercising \< 20 minutes twice per week)
* CKD patients must have stable renal function (no greater than a decline of estimated glomerular filtration (eGFR) of 1 cc/min/1.73 m2 per month over the prior 6 months) and baseline serum bicarbonate 22-24 mmol/L
* comorbid hypertension

* severe CKD (eGFR\<15 cc/min)
* metabolic alkalosis
* current treatment with bicarbonate
* ongoing drug or alcohol abuse
* diabetic neuropathy, autonomic dysfunction
* any serious disease that might influence survival
* anemia with hemoglobin \<10 g/dL
* clinical evidence of heart failure
* volume overload or ejection fraction below 45%
* symptomatic heart disease by EKG, stress test, and/or history
* treatment with central α-agonists (clonidine)
* myocardial infarction or cerebrovascular accident within the past six months
* uncontrolled hypertension (BP\>170/100 mm Hg)
* low BP\<100/50 mm Hg
* surgery within the past 3 months
* pregnancy or plans to become pregnant
* inability to exercise on a stationary bicycle
* contraindication to temporary withdrawal of α- and β-blockers
* peripheral arterial disease
* class 3 obesity (BMI\>40)
* hypo- or hyperkalemia (K\<3.5meq/L, K\>5.0 meq/L)
* current use of immunosuppressive medications (including but not limited to steroids, cyclophosphamide, calcineurin inhibitors, mycophenolate, biologics, methotrexate, etc)
* arteriovenous (AV) fistula/graft
* any contraindication to MR scanning including cardiac pacemaker, cochlear implants, neurostimulators, implanted devices with metal, any metal in the body that could pose a hazard during scanning, history of claustrophobia

Contacts and Locations

Study Contact

Dana DaCosta

CONTACT

404-727-7762

drdacos@emory.edu

Jeanie Park, MD

CONTACT

404-321-6111

Principal Investigator

Jeanie Park, MD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory Clinic

Atlanta, Georgia, 30322

United States

Atlanta VA Medical Center

Decatur, Georgia, 30033

United States

Collaborators and Investigators

Sponsor: Emory University

Jeanie Park, MD, 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 Date2022-11-11

Study Completion Date2028-06-01

Study Record Updates

Study Start Date2022-11-11

Study Completion Date2028-06-01

Terms related to this study

Keywords Provided by Researchers

Exercise training
Sodium bicarbonate
Exercise pressor reflex

Additional Relevant MeSH Terms

Chronic Kidney Disease