Sympatholysis in Chronic Kidney Disease

This study is looking into why people with chronic kidney disease (CKD) have trouble exercising and experience increased blood pressure during physical activity. Researchers want to understand if problems with blood vessel widening or narrowing play a role. You might be eligible if you are a veteran aged 18-75 with Stage III or IV CKD, a kidney transplant recipient, or a veteran without kidney disease who exercises less than twice a week. The study is testing if taking Sodium Bicarbonate tablets or a placebo (an inactive pill) before exercise or stretching can help. The main goals are to see how these interventions affect muscle oxygen, muscle pH (acidity), and blood vessel narrowing after 12 weeks. The current status of the study is unclear, and it plans to enroll 110 participants.

Study design
This is an interventional study that plans to enroll 110 participants. It compares different interventions like Sodium Bicarbonate, placebo, exercise training, and stretching.
What's involved
Participants will take Sodium Bicarbonate or a placebo before exercise or stretching sessions, 3 times per week for 6-12 weeks. Serum bicarbonate levels will be monitored regularly.
Compensation
Not stated in the trial record.
Follow-up
Changes in muscle oxygenation, muscle pH, and venoconstriction will be measured at 12 weeks after the start of the study.

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NCT02411773

Sympatholysis in Chronic Kidney Disease

Recruiting
PHASE1Ages 18–75InterventionalBasic science
Emory University
~110 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Sodium BicarbonatePlaceboExercise TrainingControl to Exercise (Stretching)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in muscle oxygenation after exercise/stretching training
Measured over Baseline, Week 12
+2 more outcomes measured
Chronic Kidney Disease
1 sites across 1 states
Georgia1
  • Jeanie Park, MD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

Veterans with Stages III and IV Chronic Kidney Disease (CKD)
Kidney transplant recipients with varying degrees of kidney function
Veterans 18-75 years old, without kidney disease, as study controls
Exercise less than 20 minutes twice per week
Willing and able to cooperate with the protocol

Exclusion

Severe CKD (estimated glomerular filtration rate (eGFR) \< 15 cc/minute)
Metabolic alkalosis (serum bicarbonate \> 28 meq/L)
Ongoing drug or alcohol abuse
Diabetic neuropathy
Any serious systemic disease that might influence survival
Severe anemia with hemoglobin (Hbg) level \< 10 g/dL
Clinical evidence of congestive heart failure or ejection fraction below 35%
Symptomatic heart disease determined by prior electrocardiogram, stress test, and/or history
Treatment with central alpha agonists (clonidine)
Uncontrolled hypertension with blood pressure (BP) greater than 170/100 mmHg
Low blood pressure with BP less than 100/50 mmHg
Pregnancy or plans to become pregnant
Current treatment with monoamine oxidase inhibitors (MAOIs)
Inability to exercise on a stationary bicycle
  • Change in muscle oxygenation after exercise/stretching trainingBaseline, Week 12

    Near-infrared spectroscopy (NIRS) will measure and record tissue oxyhemoglobin, deoxyhemoglobin, and total hemoglobin.

  • Change in muscle interstitial pH after exercise/stretching trainingBaseline, Week 12

    Near-infrared spectroscopy (NIRS) will give an estimation of the pH levels within the muscle interstitial space. Muscle interstitial pH markedly decreases during exercise, and is often lower than blood pH with a larger intracellular to interstitial pH gradient. CKD patients may have less ability to buffer pH changes in the interstitial space during exercise. Bicarbonate supplementation may improve muscle interstitial buffering capacity during exercise, and prevent exaggerated reductions in muscle interstitial pH during exercise.

  • Change in venoconstriction after exercise/stretching trainingBaseline, Week 12

    Dorsal hand vein model will be used to assess vascular alpha-1 adrenergic responsiveness by measuring the degree of venous constriction in response to varying dosages of local phenylephrine (PE) infusion.