Conditions: Improve Endothelial Function and Decrease Vascular Stenosis
Keywords: Arteriovenous Fistulas (AVFS) Hemodialysis Fistula Maturation (HFM) Flow-Mediated Dilation (FMD) Nitroglycerin-Mediated (NMD) Venous Plethysmography (VP)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: no

Brief summary:
Patients with stage IV and V chronic kidney disease and end stage renal disease requiring hemodialysis at University of Alabama at Birmingham (UAB) Dialysis Clinics will be recruited from the UAB Vascular Access Clinic, which has been the site for recruitment of patients requiring new vascular access for the last 10 years.

Detailed description:
The main purpose of this research study is to conduct a research study to determine if Sildenafil compared to placebo will improve the vascular health of arteries and veins before arteriovenous fistula creation (shunt) and how quickly your veins and arteries dilate and increase in blood flow after fistula creation. An arteriovenous fistula (shunt) is a connection between the artery and vein in the arm for dialysis use. Another purpose of this study is to determine if Sildenafil reduces the blood and tissue levels of oxidants prior to fistula creation. Oxidants are harmful substances in the body that damage the cells tissues, and organs.

Arms:
arm 1: 20 mg twice a day orally arm 2: Placebo twice a day orally

Interventions: intervention 1: Sildenafil intervention 2: Placebo
Intervention descriptions: intervention 1: Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis. intervention 2: Placebo will be over encapsulated to identical to drug comparison

Protocol document:
Prot_SAP_000.pdf: