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Sympatholysis in Chronic Kidney Disease (Sym-CKD)

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ClinicalTrials.gov Identifier: NCT02411773
Recruitment Status : Recruiting
First Posted : April 8, 2015
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate).

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Sodium Bicarbonate Drug: Placebo Other: Exercise Training Other: Stretching Phase 2

Detailed Description:
Patients with chronic kidney disease (CKD) suffer from exercise intolerance and poor physical capacity which contributes to increased cardiovascular risk in this patient population. Prior studies have shown that CKD patients have an exaggerated increase in blood pressure (BP) during both static and rhythmic exercise. Such abnormal hemodynamic responses to exercise can contribute to poor physical capacity and abnormal muscle blood flow during exercise in these patients. The goals of this project are to investigate the mechanisms and potential therapies targeting the abnormal hemodynamic response during exercise in CKD by examining the roles of impaired vasodilation, and exaggerated vasoconstriction.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Sympatholysis and Exercise Intolerance in Chronic Kidney Disease
Study Start Date : May 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Exercise Training/Sodium Bicarbonate
Subjects with CKD will undergo exercise training on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. Additionally, subjects will take 1300-2600 mg (2-4 pills) of sodium bicarbonate prior to each exercise session three times a week.
Drug: Sodium Bicarbonate
Sodium bicarbonate tablet is 650 mg for one tablet. Oral sodium bicarbonate will be given out as 1300mg-2600mg (2-4 pills) prior to each exercise or stretching session. Serum bicarbonate measurements will be monitored throughout the study (at 2 weeks, then every 2-4 weeks thereafter), and bicarbonate dosages will be adjusted to avoid metabolic alkalosis (serum HCO3 > 30).
Other: Exercise Training
Exercise training consists of riding a stationary bicycle for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. The exercise program will follow the guidelines provided by the American College of Sports Medicine (ACSM) for optimizing cardiovascular fitness. Exercise intensity will begin at low levels (50 percent of resting heart rate) and increase to no greater than 80 percent of resting heart rate. Exercise time will progress, depending on subject's progress, from 20 minutes per session at first, to a maximum of 45 minutes. Trained staff members will give instructions throughout each exercise session. Before beginning each exercise session, subjects will be instructed on a warm-up focusing on preparing the legs for activity.
Active Comparator: Exercise Training/Placebo
Subjects with CKD will undergo exercise training on a stationary bicycle,for 20-45 minutes, 3 times per week, for 6-12 weeks. Additionally, subjects will take 2-4 placebo tablets prior to each exercise session three times a week.
Drug: Placebo
2-4 placebo pills will be given out prior to each exercise or stretching session
Other: Exercise Training
Exercise training consists of riding a stationary bicycle for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. The exercise program will follow the guidelines provided by the American College of Sports Medicine (ACSM) for optimizing cardiovascular fitness. Exercise intensity will begin at low levels (50 percent of resting heart rate) and increase to no greater than 80 percent of resting heart rate. Exercise time will progress, depending on subject's progress, from 20 minutes per session at first, to a maximum of 45 minutes. Trained staff members will give instructions throughout each exercise session. Before beginning each exercise session, subjects will be instructed on a warm-up focusing on preparing the legs for activity.
Active Comparator: Stretching/Sodium Bicarbonate
Subjects with CKD will undergo progressive whole body stretching and toning exercises 3 times a week for 20-45 minutes for 6-12 weeks. Additionally, subjects will take 1300-2600 mg (2-4 pills) of sodium bicarbonate prior to each stretching session three times a week.
Drug: Sodium Bicarbonate
Sodium bicarbonate tablet is 650 mg for one tablet. Oral sodium bicarbonate will be given out as 1300mg-2600mg (2-4 pills) prior to each exercise or stretching session. Serum bicarbonate measurements will be monitored throughout the study (at 2 weeks, then every 2-4 weeks thereafter), and bicarbonate dosages will be adjusted to avoid metabolic alkalosis (serum HCO3 > 30).
Other: Stretching
Stretching exercise will consist of muscle stretching and toning for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. Trained staff members will guide subjects with the stretching exercises, and activities are designed to increase flexibility and range of motion. Before beginning each stretching exercise session, subjects will be instructed to warm-up.
Placebo Comparator: Stretching/Placebo
Subjects with CKD will undergo progressive whole body stretching and toning exercises 3 times a week for 20-45 minutes for 6-12 weeks. Additionally, subjects will take 2-4 placebo tablets prior to each exercise session three times a week.
Drug: Placebo
2-4 placebo pills will be given out prior to each exercise or stretching session
Other: Stretching
Stretching exercise will consist of muscle stretching and toning for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. Trained staff members will guide subjects with the stretching exercises, and activities are designed to increase flexibility and range of motion. Before beginning each stretching exercise session, subjects will be instructed to warm-up.
No Intervention: Control
Healthy subjects without CKD will not receive any interventions.


Outcome Measures

Primary Outcome Measures :
  1. Change in muscle oxygenation after exercise/stretching training [ Time Frame: Baseline, 12 weeks ]
    Near-infrared spectroscopy (NIRS) will measure and record tissue oxyhemoglobin, deoxyhemoglobin, and total hemoglobin.

  2. Change in muscle interstitial pH after exercise/stretching training [ Time Frame: Baseline, 12 weeks ]
    Near-infrared spectroscopy (NIRS) will give an estimation of the pH levels within the muscle interstitial space.

  3. Change in venoconstriction after exercise/stretching training [ Time Frame: Baseline, 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in muscle oxygenation after handgrip exercise [ Time Frame: Baseline, 30 minutes ]
    Near-infrared spectroscopy (NIRS) will measure and record tissue oxyhemoglobin, deoxyhemoglobin, and total hemoglobin.

  2. Change in muscle interstitial pH after handgrip exercise [ Time Frame: Baseline, 30 minutes ]
    Near-infrared spectroscopy (NIRS) will give an estimation of the pH levels within the muscle interstitial space.

  3. Change in venoconstriction after phenylephrine [ Time Frame: Baseline, 30 minutes ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veterans with Stages III and IV Chronic Kidney Disease (CKD)
  • 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 Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411773


Contacts
Contact: Dana DaCosta 404-727-7762 drdacos@emory.edu

Locations
United States, Georgia
Atlanta VA Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Dana DaCosta    404-727-7762    drdacos@emory.edu   
Principal Investigator: Jeanie Park, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Jeanie Park, MD Emory University
More Information

Responsible Party: Jeanie Park, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02411773     History of Changes
Other Study ID Numbers: IRB00078214
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency