Completed

EFAVFEndothelial Function and Arterio-Venous Fistula Maturation

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Congenital Abnormalities+21

+ Urogenital Diseases

+ Arteriovenous Fistula

From 18 to 90 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2010
See protocol details

Summary

Principal SponsorUniversity of California, San Francisco
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2010

Actual date on which the first participant was enrolled.

Current practice guidelines stipulate that 65% of all prevalent ESRD patients should receive HD through some sort of arterio-venous fistula (AVF). An AVF is a subcutaneous, permanent vascular access created surgically by connecting a vein with an artery and is the preferred mode of access due to lower rates of infection or thrombosis compared to prosthetic grafts or tunneled lines. An AVF is mature if it can sustain high quality HD. However, rates of primary failure (the inability of an AVF to sustain HD) are high, ranging from 40-70%. Traditional coronary risk factors such as hypertension, hypercholesterolemia, and diabetes mellitus, have limited ability to allow surgeons to predict which AVFs will mature. One possible explanation involves vascular remodeling, the structural changes which occur in a blood vessel in response to hemodynamic stimuli. The endothelial, lying at the interface of the vessel wall and flowing blood, is a "biosensor", responding to changes in blood flow and pressure. It initiates a complex biological response including cellular proliferation and migration, matrix degradation, and cellular apoptosis. This longitudinal, observational study hypothesizes that endothelial function is a critical modulator of AVF maturation. Specifically, that patients with inflammation will have impaired endothelial function and demonstrate less significant remodeling than others.

Official TitleEndothelial Function and Arterio-Venous Fistula Maturation
NCT01604473
Principal SponsorUniversity of California, San Francisco
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesUrogenital DiseasesArteriovenous FistulaArteriovenous MalformationsCardiovascular DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsFistulaKidney DiseasesKidney Failure, ChronicCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesVascular DiseasesVascular FistulaCardiovascular AbnormalitiesPathological Conditions, AnatomicalDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesVascular Malformations

Criteria

4 inclusion criteria required to participate
Chronic Kidney Disease classification Stage IV or V

Adequate quality cephalic or basilic vein based on pre-operative assessment

Able to provide written informed consent

Able to travel to the SFVA Medical Center or UCSF Medical Center for follow-up examination

7 exclusion criteria prevent from participating
Age >90 or < 18 years

Diagnosed hypercoaguble state

Recent surgery or other major illness or infection within 6 weeks

Use of immunosuppresive medication

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

San Francisco VA Medical Center

San Francisco, United StatesOpen San Francisco VA Medical Center in Google Maps
Suspended

University of California, San Francisco Medical Center

San Francisco, United States
Completed2 Study Centers