Sympatholysis in Chronic Kidney Disease (Sym-CKD)

Emory University

Status and phase: Enrolling; Phase 1

Conditions: Chronic Kidney Disease

Treatments: Drug: Placebo; Behavioral: Control to Exercise (Stretching); Behavioral: Exercise Training; Drug: Sodium Bicarbonate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02411773

IRB00078214

Details and patient eligibility

About

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).

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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110 participants in 5 patient groups, including a placebo group

Exercise Training plus Sodium Bicarbonate

Active Comparator group

Description:

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.

Treatment:

Drug: Sodium Bicarbonate

Behavioral: Exercise Training

Exercise Training plus Placebo

Active Comparator group

Description:

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.

Treatment:

Behavioral: Exercise Training

Drug: Placebo

Control to Exercise (Stretching) plus Sodium Bicarbonate

Active Comparator group

Description:

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.

Treatment:

Drug: Sodium Bicarbonate

Behavioral: Control to Exercise (Stretching)

Control to Exercise (Stretching) plus Placebo

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Control to Exercise (Stretching)

Drug: Placebo

Healthy Control

No Intervention group

Description:

Healthy subjects without CKD will not receive any interventions.