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
| NCT number | NCT02414204 |
| Other study ID # | F150220002 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2015 |
| Est. completion date | June 30, 2018 |
| Verified date | August 2019 |
| Source | University of Alabama at Birmingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alabama at Birmingham |
United States,
| 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 |