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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

Primary Purpose

Improve Endothelial Function and Decrease Vascular Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sildenafil
Placebo
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Improve Endothelial Function and Decrease Vascular Stenosis focused on measuring Arteriovenous Fistulas (AVFS), Hemodialysis Fistula Maturation (HFM), Flow-Mediated Dilation (FMD), Nitroglycerin-Mediated (NMD), Venous Plethysmography (VP)

Eligibility Criteria

19 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sildenafil

Placebo

Arm Description

20 mg twice a day orally

Placebo twice a day orally

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 1, 2015
Last Updated
August 8, 2019
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02414204
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sildenafil
Arm Type
Active Comparator
Arm Description
20 mg twice a day orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice a day orally
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
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 Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be over encapsulated to identical to drug comparison
Primary Outcome Measure Information:
Title
Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With a Change in Blood Flow Rate
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥19 years of age male or female Chronic Kidney Disease Stage IV or V patients or End Stage Renal Disease Patient requiring arteriovenous fistula surgery Exclusion Criteria: Patient currently on nitrate therapy or any nitric oxide donor in any form Patient currently on protease inhibitor or non-nucleoside reverse transcriptase inhibitor Patient with resting systolic blood pressure <90 mm Hg and diastolic blood pressure < 50 mm Hg. Patient life expectancy < nine months. Patient unable or unwilling to meet study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timmy Lee, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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