| Trial ID: | L1563 |
| Source ID: | NCT02414204
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| Associated Drug: |
Sildenafil
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| 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
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02414204/results
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| Conditions: |
Improve Endothelial Function and Decrease Vascular Stenosis
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| Interventions: |
DRUG: Sildenafil|OTHER: Placebo
|
| Outcome Measures: |
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
|
| Sponsor/Collaborators: |
Sponsor: University of Alabama at Birmingham
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
4
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-04
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| Completion Date: |
2018-06-30
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| Results First Posted: |
2018-08-21
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| Last Update Posted: |
2019-08-12
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| Locations: |
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02414204
|
