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

NCT02414204 | Completed Results

• 1 other identifier: F150220002
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With a Change in Blood Flow Rate

  6 weeks

Study Arms (2)

Sildenafil

ACTIVE COMPARATOR

20 mg twice a day orally

Drug: Sildenafil

Placebo

PLACEBO COMPARATOR

Placebo twice a day orally

Other: Placebo

Interventions

Sildenafil DRUG

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.

Sildenafil

Placebo OTHER

Placebo will be over encapsulated to identical to drug comparison

Placebo

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

This was a pilot study. Only four participants were recruited during the study period.

Results Point of Contact

• Title: Timmy Lee
• Organization: UNIVERSITY OF ALABAMA AT BIRMINGHAM

txlee@uab.edu

205-934-3589

Study Officials

• Timmy Lee, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 10, 2015
• Study Start: April 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2018
• Last Updated: August 12, 2019
• Results First Posted: August 21, 2018

Record last verified: 2019-08

Locations

US (1)