NCT01356966

Exercise Intolerance in Renal Failure

The Role of Neurovascular Dysfunction and Oxidative Stress in the Exercise Intolerance of Renal Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Patients with chronic kidney disease have profound exercise intolerance which contributes to an increased risk of cardiovascular disease. The investigators have found that chronic kidney disease patients have an exaggerated increase in blood pressure during certain forms of exercise that could certainly contribute to exercise dysfunction as well as cardiovascular risk. The investigators will test the mechanisms underlying this exaggerated blood pressure response, as well as the potential benefits of short-term tetrahydrobiopterin (BH4) with folic acid on both exercise dysfunction and cardiovascular risk factors in chronic kidney disease. The investigators will test whether short-term treatment with tetrahydrobiopterin (BH4), a cofactor for nitric oxide, together with folic acid improves inflammation, vascular health, and adrenaline levels, both at rest and during exercise in chronic kidney disease.

Conditions

• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	Tetrahydrobiopterin	Tetrahydrobiopterin (BH4) 200 mg PO BID for 12 weeks
DRUG	Placebo	2 placebo pills PO BID for12 weeks
DIETARY_SUPPLEMENT	Folate	Folate 1 mg daily for 12 weeks

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-05-20
• Last updated: 2015-06-01
• Results posted: 2015-06-01

Locations

2 sites across 1 country: United States