Neurovascular Transduction During Exercise in Chronic Kidney Disease
This study is looking into why people with chronic kidney disease (CKD) have trouble exercising and experience high blood pressure during physical activity. Researchers want to understand if increased adrenaline or blood vessel issues are contributing factors. They will test if regular exercise on a bicycle, or taking 6R-BH4 (Kuvan) pills, or histidine and beta-alanine supplements can improve these problems. 6R-BH4 is approved for a different condition (phenylketonuria) but not currently for blood pressure or exercise capacity in CKD. You may be able to join if you are 18-75 years old and have Stage III or IV CKD, meaning your kidney function (eGFR) is between 15-59 cc/minute. The study aims to see if these interventions change how your body responds to exercise and how your blood vessels react.
- Study design
- This is an interventional study with a planned enrollment of 150 participants. It is not specified if the study is randomized or blinded.
- What's involved
- Participants will take study pills (6R-BH4 or placebo) twice daily for 12 weeks, and 1 mg of folic acid daily for 12 weeks. Some participants will exercise 3 times a week on a stationary ergometer, while others will do stretching exercises.
- Compensation
- Not stated in the trial record.
- Follow-up
- Changes in functional sympatholysis, vascular alpha 1 adrenergic responsiveness, and exaggerated pressor responses during exercise will be measured at Baseline and Week 12.
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Neurovascular Transduction During Exercise in Chronic Kidney Disease
At a glance
Conditions
NCT02947750
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Atlanta VA Health Care System
Decatur, Georgiastudy coordinator listed
Recruiting
Emory University Hospital
Atlanta, Georgiastudy coordinator listed
Recruiting
Emory University Hospital Midtown
Atlanta, Georgiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Joe Nocera, PhD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Change in functional sympatholysisBaseline, Week 12
Muscle oxygenation during exercise and sympathoexcitation will be measured.
- Change in vascular alpha 1 adrenergic responsivenessBaseline, Week 12
Changes in vascular diameter in response to phenylephrine will be measured.
- Change in exaggerated pressor responses during exerciseBaseline, Week 12
Blood pressure and sympathetic responses during exercise will be measured.