Sympatholysis in Chronic Kidney Disease

Официальное название

Functional Sympatholysis and Exercise Intolerance in Chronic Kidney Disease

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат 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 bicarbonate \> 30).
• Препарат Placebo
  2-4 placebo pills will be given out prior to each exercise or stretching session.
• Поведенческое 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 pr
• Поведенческое Control to Exercise (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.

Первичные конечные точки

• Change in muscle oxygenation after exercise/stretching training [Срок оценки: Baseline, Week 12]
• Change in muscle interstitial pH after exercise/stretching training [Срок оценки: Baseline, Week 12]
• Change in venoconstriction after exercise/stretching training [Срок оценки: Baseline, Week 12]

Вторичные конечные точки (3)

• Change in Functional Sympatholysis [Срок оценки: Baseline, 30 minutes]
• Change in muscle interstitial pH after handgrip exercise [Срок оценки: Baseline, 30 minutes]
• Change in Venoconstriction after Phenylephrine [Срок оценки: Baseline, 30 minutes]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Atlanta VA Medical Center — Decatur

Идентификаторы

NCT: NCT02411773 · IRB00078214 · 2025P011323

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗