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

Improve Endothelial Function and Decrease Vascular Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414204
• Other study ID #: F150220002
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Improve Endothelial Function and Decrease Vascular Stenosis
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic
• Vascular Remodeling

Intervention

Drug:
• Sildenafil
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.

Other:
• Placebo
Placebo will be over encapsulated to identical to drug comparison

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group	For flow mediated dilation studies (FMD), the brachial artery diameter was measured by ultrasound at baseline. An automated floor pressure cuff was inflated on the upper arm to a suprasystolic pressure that was sustained for 5 minutes, and the brachial diameter measurement was repeated 55-65 seconds after releasing the cuff. FMD was calculated as the percentage change in arterial diameter from baseline.; For venous occlusion plethysmography studies (VP), forearm volume was measured using a strain-gauge plethysmography device during application of an upper arm BP cuff at increasing but subsystolic pressures. Venous capacitance slope was estimated from the volume-pressure relationship and expressed as a percentage increase in volume per millimeters of mercury.; The change at baseline and 2 weeks in these measurements between the sildenafil and placebo group will be assessed.	2 weeks
Secondary	Number of Participants With a Change in Blood Flow Rate	Blood flow of the fistula at 6 weeks is measured with doppler ultrasound and values of the fistula artery and vein are obtained (ml/min). The difference in blood flow rates of the fistula artery and vein between the sildenafil treated group and placebo group will be assessed.	6 weeks