Improve Endothelial Function and Decrease Vascular StenosisNCT02414204

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

A study testing Sildenafil in people with Improve Endothelial Function and Decrease Vascular Stenosis, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 19 to 99 years
Conditions the study is for: Improve Endothelial Function and Decrease Vascular Stenosis
What is being tested?: Sildenafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: 1 siteUnited States
Study dates: Apr 2015to 30 Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35294

Other trials in United States

About this study

Read the 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.

Conditions: Improve Endothelial Function and Decrease Vascular Stenosis
Being tested: Sildenafil, Placebo
Keywords: Arteriovenous Fistulas (AVFS), Hemodialysis Fistula Maturation (HFM), Flow-Mediated Dilation (FMD), Nitroglycerin-Mediated (NMD), Venous Plethysmography (VP)
Medical subject headings: Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SildenafilDrug
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.
PlaceboOther
Placebo will be over encapsulated to identical to drug comparison

Study groups in NCT02414204
Study group	Role	What they receive
Sildenafil	Active comparator	20 mg twice a day orally Receives: Drug: Sildenafil
Placebo	Placebo comparator	Placebo twice a day orally Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 weeks

Secondary outcomes (1)

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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201530 Jun 2018

First posted10 Apr 2015 (estimated)
Study startApr 2015
Primary completion30 Jun 2017
Study completion30 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Improve Endothelial Function and Decrease Vascular StenosisStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02414204
Sponsor's protocol ID: F150220002
Status last verified: Aug 2019
First submitted: 1 Apr 2015
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02414204
Acronym / sponsor ID: F150220002
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)
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: Apr 2015
Primary completion: 30 Jun 2017 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 10 Apr 2015 (estimated)
Results: Posted 21 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Sildenafil	Active comparator	Drug: Sildenafil20 mg twice a day orally
Placebo	Placebo comparator	Other: PlaceboPlacebo twice a day orally

Who may qualify

Ages: 19 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SildenafilSildenafil, 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.	Drug	Sildenafil
PlaceboPlacebo will be over encapsulated to identical to drug comparison	Other	Placebo

Primary outcome

Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group
Time frame: 2 weeks
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.

1 secondary outcome

Number of Participants With a Change in Blood Flow Rate
Time frame: 6 weeks

Results and safety

Results posted to the registry on 21 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sildenafil	2	2
Placebo	2	2

Primary outcome: Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group

Time frame: 2 weeks. Mean (Standard Error). Unit: Change in FMD%

Measure	Sildenafil n = 2	Placebo n = 2
Value	10.8 (8.0)	8.6 (2.9)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from time of enrollment until 6 weeks following Arteriovenous Fistula (AVF) surgery. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sildenafil	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): This was a pilot study. Only four participants were recruited during the study period.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timmy Lee, MD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sildenafil in people with Improve Endothelial Function and Decrease Vascular Stenosis, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02414204.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.