Understanding exercise capacity in chronic kidney disease patients
Functional Sympatholysis and Exercise Intolerance in Chronic Kidney Disease
PHASE1 · Emory University · NCT02411773
This study is trying to find out why people with chronic kidney disease have trouble exercising and high blood pressure during workouts, and it will test different treatments to see if they can help improve exercise ability.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 1 site (Decatur, Georgia) |
| Trial ID | NCT02411773 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the reasons behind poor exercise capacity and increased blood pressure during exercise in patients with chronic kidney disease (CKD). It will investigate the mechanisms of impaired blood vessel dilation and exaggerated vasoconstriction that contribute to these issues. The study will involve interventions such as sodium bicarbonate, placebo, and exercise training to assess their effects on hemodynamic responses during exercise. By understanding these mechanisms, the research seeks to identify potential therapies to improve exercise tolerance in CKD patients.
Who should consider this trial
Good fit: Ideal candidates include veterans aged 18-75 with stages III and IV chronic kidney disease or kidney transplant recipients with varying kidney function.
Not a fit: Patients with severe chronic kidney disease, ongoing substance abuse, or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise capacity and reduced cardiovascular risk for patients with chronic kidney disease.
How similar studies have performed: Previous studies have indicated abnormal hemodynamic responses in CKD patients, suggesting that this approach may yield valuable insights, although it may also explore novel mechanisms.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Decatur, Georgia
- Atlanta VA Medical Center — Decatur, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Jeanie Park, MD — Emory University
- Study coordinator: Dana DaCosta
- Email: drdacos@emory.edu
- Phone: 404-727-7762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Disease