Phosphodiesterase Type 5 Inhibition to Improve Endothelial Function and Vascular Remodeling in Chronic Kidney Disease and End Stage Renal Disease Patients Requiring New Arteriovenous Fistula

The University of Alabama at Birmingham

Status: Completed

Conditions: Improve Endothelial Function and Decrease Vascular Stenosis

Treatments: Other: Placebo; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT02414204

F150220002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 19 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥19 years of age male or female
2. Chronic Kidney Disease Stage IV or V patients or End Stage Renal Disease Patient requiring arteriovenous fistula surgery

Exclusion criteria

1. Patient currently on nitrate therapy or any nitric oxide donor in any form
2. Patient currently on protease inhibitor or non-nucleoside reverse transcriptase inhibitor
3. Patient with resting systolic blood pressure <90 mm Hg and diastolic blood pressure < 50 mm Hg.
4. Patient life expectancy < nine months.
5. Patient unable or unwilling to meet study requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

4 participants in 2 patient groups, including a placebo group

Sildenafil

Active Comparator group

Description:

20 mg twice a day orally

Treatment:

Drug: Sildenafil

Placebo

Placebo Comparator group

Description:

Placebo twice a day orally

Treatment:

Other: Placebo