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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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02414204
First Posted: April 10, 2015
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Timmy Lee, MD, University of Alabama at Birmingham
  Purpose
Patients with stage IV and V chronic kidney disease and end stage renal disease requiring hemodialysis at 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.

Condition Intervention
Improve Endothelial Function and Decrease Vascular Stenosis Drug: Sildenafil Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Timmy Lee, MD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in baseline and 2 week FMD/VP measurements [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Change in blood flow with vein and artery diameters increased at 2 weeks [ Time Frame: 2 weeks ]
  • Change in blood flow with vein and artery diameters increased at 6 weeks [ Time Frame: 6 weeks ]

Estimated Enrollment: 21
Study Start Date: April 2015
Estimated Study Completion Date: January 2018
Primary Completion Date: June 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sildenafil
20 mg twice a day orally
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.
Placebo Comparator: Placebo
Placebo twice a day orally
Other: Placebo
Placebo will be over encapsulated to identical to drug comparison

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414204


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Timmy Lee, MD University of Alabama at Birmingham
  More Information

Responsible Party: Timmy Lee, MD, Principal investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02414204     History of Changes
Other Study ID Numbers: F150220002
First Submitted: April 1, 2015
First Posted: April 10, 2015
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by Timmy Lee, MD, University of Alabama at Birmingham:
Arteriovenous Fistulas (AVFS)
Hemodialysis Fistula Maturation (HFM)
Flow-Mediated Dilation (FMD)
Nitroglycerin-Mediated (NMD)
Venous Plethysmography (VP)

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Fistula
Arteriovenous Fistula
Vascular Remodeling
Urologic Diseases
Renal Insufficiency
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathologic Processes
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents