End Stage Renal DiseasesAUAPAVFONCT04141358
Advanced Ultrasound Applications for Predicting AVF Outcomes
An observational study of End Stage Renal Diseases and Renal Failure, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Haemodialysis is a renal replacement therapy that can be introduced to patients with end-stage renal disease (ESRD) to help them maintain a good healthy life. The patient's blood is pumped through a dialysis machine to remove excess fluid, salt and waste, then it is pumped back into the patient's circulation system. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Diseases, Renal Failure, Chronic Kidney Diseases
- What is being tested?
- Advanced ultrasound measurements
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 1 Apr 2024
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients selected for this protocol must have the necessity to undergo surgery to receive an Arterio-Venos Fistula (AVF) for hemodialysis in either arm.
Who may be able to join
- >18 years age
- <90 years age
- End stage renal disease
- Glomerular filtration rate < 30 ml/min/1.73m2
Who cannot join
- <18 years age
- > 90 years age
- < 2cm vein diameter
- Not end-stage renal disease
- Pregnant patients will not be recruited in this study. Patients pregnancy status will be assessed on initial enrolment to exclude them from the study.
- Those unable to provide consent.
- Anyone who is taking part in any other research.
- Potential participants who might not adequately understand verbal explanations or written information given in English, or who have special communication needs will not be included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Ultrasound 2D Strain Speckle Tracking, 2D Shear Wave Elastography and Transonic Flowmeter as Diagnostic and Potential Predictor Tool for Arteriovenous Fistula Outcomes With End Stage Renal Failure.
Haemodialysis is a renal replacement therapy that can be introduced to patients with end-stage renal disease (ESRD) to help them maintain a good healthy life. The patient's blood is pumped through a dialysis machine to remove excess fluid, salt and waste, then it is pumped back into the patient's circulation system. In order to carry out haemodialysis, vascular access (VA) is required to connect the patient to the dialysis machine. Patients have only three options of vascular access: arteriovenous fistula (AVF), an anastomosis between a native vein and an artery; arteriovenous graft (AVG), a connection between a synthetic tube and native blood vessels; and (3) central line, a cuffed catheter placed in a large neck vein. Arteriovenous fistulas are the preferred method for VA because of their longevity and causing the least number of complications. Although there are a number of factors that may increase the probability of AVF failure rate such as age and gender of the patient, poor native vessel structure, medications and the level of surgical experience, 30-40% of new AVFs fail to mature for unknown reasons. For an AVF to become functionally mature postoperative, remodelling and dilation of the native artery and vein are essential to accommodate significantly increased blood flow. However, pre-existing diseases in patients with ESRD such as arterial stiffness and endothelial dysfunction may impair AVF and preclude dialysis. It has been asserted that the lack of AVF success is attributable to insufficient arterial dilation because of poor arterial wall elasticity.
The study aims to investigate the role of arterial stiffness and endothelial dysfunction in predicting AVF outcome using novel non-invasive ultrasound applications: 2D shear wave elastography and 2D strain speckle tracking will be employed to assess arterial stiffness, while an intraoperative flow-mediated dilation (FMD) technique will be used to evaluate endothelial dysfunction.
Read the detailed description
This is an observational prospective pilot study of patients with end-stage renal disease (ESRD), who will be referred for AVF procedure.
Duration: 21 Months The research team will collect data from the patients after they have signed the informed consent form. Data collection will take place before, during and after arteriovenous fistula (AVF) surgery.
At 0 week, the patient will be interviewed to obtain clinical information. Also, blood pressure and body mass index will be checked and recorded. Next, pre-operative AVF assessment ultrasound measurements will be performed to assess flow, pulsatility and vessel diameter. Advanced ultrasound applications(2D strain speckle tracking and 2D Shear wave elastography) will be applied to assess arterial stiffness as additional measurement tools. These are quantitative measures of vessel stiffness. It takes less than five minutes to obtain these measurements from the imaged vessel.
During AVF surgery, the endothelial function will be assessed intraoperatively by testing the ability of the endothelium to dilate, flow mediation dilation (FMD). Leftover vessel specimens will be collected for histopathological analysis purpose.
At 6 week, post-AVF ultrasound assessment will be conducted to assess the maturation of AVF by measuring ultrasound parameters of blood flow, pulsatility and vessel diameter. Arterial stiffness parameters will be measured as well. Blood pressure and BMI will be assessed and recorded.
Study data will be entered into a study database which will consist of a password encrypted stored on a password-protected computer in the vascular lab at Hammersmith Hospital. Only the study researchers will know the study database password.
Data analysis will be performed after the enrolment of 20, 40 and 75 patients.
- Being tested
- Advanced ultrasound measurements
- Keywords
- Vascular Access, Endothelial Dysfunction, Vascular Stiffness, Arteriovenous Fistula
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced ultrasound measurementsDiagnostic test
Clinical interventions and procedures:
- Consent at 0 week
- Clinical data collection at 0 week
- Strain for native artery at 0 week
- Young's modulus for native artery at 0 week
- Intimal medial thickness for native artery at 0 week
- Ultrasound blood volume flow measurement at 0 week
- Vessel diameter at 0 week
- Blood pressure at 0 week
- BMI at 0 week
- Intra-operative blood volume flow measurement at AVF surgery time
- Strain for native artery at 6 weeks
- Young's modulus native artery at 6 weeks
- Intimal medial thickness native artery arteries at 6 weeks
- Ultrasound blood volume flow measurement at 6 weeks
- Vessel diameter at 6 weeks
- Blood pressure at 6 weeks
- BMI at 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with end-stage renal disease who will undergo arteriovenous fistula (AVF) surgery will be recruited and follow-up them up to 6 weeks or until the AVF become suitable for hemodialysis. Receives: Diagnostic Test: Advanced ultrasound measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency of arteriovenous fistula according to ultrasound parameters
Rate of blood volume flow >400 mL/min.
Measured: 6 Weeks
Arteriovenous fistula diameter
Fistula considered to be patent if there is a minimum venous diameter of ≥ 5 mm.
Measured: 6 Weeks
Secondary outcomes (1)
Number of arteriovenous fistula successful use for haemodialysis.
≥ 3 uses on separate occasions post-arteriovenous fistula surgery.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Nov 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseasesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed Aslam, PhD, Study director, Academic Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141358
- Sponsor's protocol ID
- 19HH5550
- Acronym
- AUAPAVFO
- Status last verified
- Mar 2026
- First submitted
- 23 Oct 2019
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kheda MF, Brenner LE, Patel MJ, Wynn JJ, White JJ, Prisant LM, Jones SA, Paulson WD. Influence of arterial elasticity and vessel dilatation on arteriovenous fistula maturation: a prospective cohort study. Nephrol Dial Transplant. 2010 Feb;25(2):525-31. doi: 10.1093/ndt/gfp462. Epub 2009 Sep 15.
PubMed 19755475McGrogan DG, Maxwell AP, Khawaja AZ, Inston NG. Current tools for prediction of arteriovenous fistula outcomes. Clin Kidney J. 2015 Jun;8(3):282-9. doi: 10.1093/ckj/sfv019. Epub 2015 Apr 2.
PubMed 26034589Owens CD, Wake N, Kim JM, Hentschel D, Conte MS, Schanzer A. Endothelial function predicts positive arterial-venous fistula remodeling in subjects with stage IV and V chronic kidney disease. J Vasc Access. 2010 Oct-Dec;11(4):329-34. doi: 10.5301/jva.2010.5833.
PubMed 21038305
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ultrasound 2D Strain Speckle Tracking, 2D Shear Wave Elastography and Transonic Flowmeter as Diagnostic and Potential Predictor Tool for Arteriovenous Fistula Outcomes With End Stage Renal Failure.
- ClinicalTrials.gov ID
- NCT04141358
- Acronym / sponsor ID
- AUAPAVFO / 19HH5550
- Keywords
- Vascular Access, Endothelial Dysfunction, Vascular Stiffness, Arteriovenous Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Haemodialysis is a renal replacement therapy that can be introduced to patients with end-stage renal disease (ESRD) to help them maintain a good healthy life. The patient's blood is pumped through a dialysis machine to remove excess fluid, salt and waste, then it is pumped back into the patient's circulation system. In order to carry out haemodialysis, vascular access (VA) is required to connect the patient to the dialysis machine. Patients have only three options of vascular access: arteriovenous fistula (AVF), an anastomosis between a native vein and an artery; arteriovenous graft (AVG), a connection between a synthetic tube and native blood vessels; and (3) central line, a cuffed catheter placed in a large neck vein. Arteriovenous fistulas are the preferred method for VA because of their longevity and causing the least number of complications. Although there are a number of factors that may increase the probability of AVF failure rate such as age and gender of the patient, poor native vessel structure, medications and the level of surgical experience, 30-40% of new AVFs fail to mature for unknown reasons. For an AVF to become functionally mature postoperative, remodelling and dilation of the native artery and vein are essential to accommodate significantly increased blood flow. However, pre-existing diseases in patients with ESRD such as arterial stiffness and endothelial dysfunction may impair AVF and preclude dialysis. It has been asserted that the lack of AVF success is attributable to insufficient arterial dilation because of poor arterial wall elasticity.
The study aims to investigate the role of arterial stiffness and endothelial dysfunction in predicting AVF outcome using novel non-invasive ultrasound applications: 2D shear wave elastography and 2D strain speckle tracking will be employed to assess arterial stiffness, while an intraoperative flow-mediated dilation (FMD) technique will be used to evaluate endothelial dysfunction.
Detailed description
This is an observational prospective pilot study of patients with end-stage renal disease (ESRD), who will be referred for AVF procedure.
Duration: 21 Months The research team will collect data from the patients after they have signed the informed consent form. Data collection will take place before, during and after arteriovenous fistula (AVF) surgery.
At 0 week, the patient will be interviewed to obtain clinical information. Also, blood pressure and body mass index will be checked and recorded. Next, pre-operative AVF assessment ultrasound measurements will be performed to assess flow, pulsatility and vessel diameter. Advanced ultrasound applications(2D strain speckle tracking and 2D Shear wave elastography) will be applied to assess arterial stiffness as additional measurement tools. These are quantitative measures of vessel stiffness. It takes less than five minutes to obtain these measurements from the imaged vessel.
During AVF surgery, the endothelial function will be assessed intraoperatively by testing the ability of the endothelium to dilate, flow mediation dilation (FMD). Leftover vessel specimens will be collected for histopathological analysis purpose.
At 6 week, post-AVF ultrasound assessment will be conducted to assess the maturation of AVF by measuring ultrasound parameters of blood flow, pulsatility and vessel diameter. Arterial stiffness parameters will be measured as well. Blood pressure and BMI will be assessed and recorded.
Study data will be entered into a study database which will consist of a password encrypted stored on a password-protected computer in the vascular lab at Hammersmith Hospital. Only the study researchers will know the study database password.
Data analysis will be performed after the enrolment of 20, 40 and 75 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Advanced ultrasound measurementsPatients with end-stage renal disease who will undergo arteriovenous fistula (AVF) surgery will be recruited and follow-up them up to 6 weeks or until the AVF become suitable for hemodialysis. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected for this protocol must have the necessity to undergo surgery to receive an Arterio-Venos Fistula (AVF) for hemodialysis in either arm.
Key inclusion criteria (4 listed)
- >18 years age
- <90 years age
- End stage renal disease
- Glomerular filtration rate < 30 ml/min/1.73m2
Key exclusion criteria (8 listed)
- <18 years age
- > 90 years age
- < 2cm vein diameter
- Not end-stage renal disease
- Pregnant patients will not be recruited in this study. Patients pregnancy status will be assessed on initial enrolment to exclude them from the study.
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 |
|---|---|---|
| Advanced ultrasound measurementsClinical interventions and procedures: * Consent at 0 week * Clinical data collection at 0 week * Strain for native artery at 0 week * Young's modulus for native artery at 0 week * Intimal medial thickness for native artery at 0 week * Ultrasound blood volume flow measurement at 0 week * Vessel diameter at 0 week * Blood pressure at 0 week * BMI at 0 week * Intra-operative blood volume flow measurement at AVF surgery time * Strain for native artery at 6 weeks * Young's modulus native artery at 6 weeks * Intimal medial thickness native artery arteries at 6 weeks * Ultrasound blood volume flow measurement at 6 weeks * Vessel diameter at 6 weeks * Blood pressure at 6 weeks * BMI at 6 weeks | Diagnostic test | Study group |
Primary outcome
Patency of arteriovenous fistula according to ultrasound parameters
Time frame: 6 Weeks
Rate of blood volume flow >400 mL/min.
Arteriovenous fistula diameter
Time frame: 6 Weeks
Fistula considered to be patent if there is a minimum venous diameter of ≥ 5 mm.
1 secondary outcome
Number of arteriovenous fistula successful use for haemodialysis.
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 19755475Kheda MF, Brenner LE, Patel MJ, Wynn JJ, White JJ, Prisant LM, Jones SA, Paulson WD. Influence of arterial elasticity and vessel dilatation on arteriovenous fistula maturation: a prospective cohort study. Nephrol Dial Transplant. 2010 Feb;25(2):525-31. doi: 10.1093/ndt/gfp462. Epub 2009 Sep 15.
- Background: PubMed 26034589McGrogan DG, Maxwell AP, Khawaja AZ, Inston NG. Current tools for prediction of arteriovenous fistula outcomes. Clin Kidney J. 2015 Jun;8(3):282-9. doi: 10.1093/ckj/sfv019. Epub 2015 Apr 2.
- Background: PubMed 21038305Owens CD, Wake N, Kim JM, Hentschel D, Conte MS, Schanzer A. Endothelial function predicts positive arterial-venous fistula remodeling in subjects with stage IV and V chronic kidney disease. J Vasc Access. 2010 Oct-Dec;11(4):329-34. doi: 10.5301/jva.2010.5833.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Diseases
Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
RecruitingPhase 1
Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
End Stage Renal Disease
Not yet recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
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.
Mohammed Aslam, PhD study director
Academic Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Diseases and Renal Failure, run by Imperial College London at 1 site in United Kingdom.
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 4 inclusion and 8 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 4 Mar 2026. 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 Kingdom. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patency of arteriovenous fistula according to ultrasound parameters (time frame: 6 Weeks). The study lists 2 primary outcomes in all. 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 NCT04141358, which also lists 3 linked publications.
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 4 Mar 2026.