Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Emory University
156 participants
Nov 11, 2022
INTERVENTIONAL
Conditions
Summary
The goals of this project are to investigate the mechanisms and potential therapies related to exercise capacity in persons with chronic kidney disease (CKD).
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria24
- 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
Interventions
Participants take 650-1300 mg of sodium bicarbonate orally twice daily. Serum bicarbonate levels are measured at baseline and then every 2-4 weeks throughout the trial. Doses will be adjusted or held to avoid metabolic alkalosis.
Exercise training consists of progressive, interval-based "Spin" exercise on stationary bicycles three times per week for 12 weeks, led by a certified exercise physiologist. The duration of each session begins at 20 minutes and is increased by 1 to 2 minutes as tolerated to a goal of 45 minutes per session. Exercise intensity begins at low levels (50% of maximal heart rate reserve (HRR)) and increases by 5% every week to a goal of 75% maximal HRR. Each session includes a 5-min warm up, then an interval-based, work-out phase that includes steady up-tempo cadences, sprints, and climbs, followed by a 5-minute cool down.
Participants take placebo pills to match 650-1300 mg of sodium bicarbonate orally twice daily.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05928936