Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID06411353

The Relationship Between Blood Flow Conditions and Sounds in Arteriovenous Fistulae for Hemodialysis

Led by Mario Negri Institute for Pharmacological Research · Updated on 2025-09-04

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the connection between blood flow conditions and the sounds produced by arteriovenous fistulas (AVFs) in patients with end-stage renal disease (ESRD) who require vascular access for hemodialysis. This study aims to better understand how blood flow affects AVF function and to explore if analyzing these sounds can help predict AVF health. The trial focuses on non-drug methods to improve AVF monitoring and reduce failures. Participants will have an AVF surgically created and then undergo several diagnostic tests including non-contrast enhanced MRI scans and advanced 3D ultrasound examinations to create detailed blood flow models. The study includes a series of visits starting with screening and enrollment, surgery day, and follow-up visits at 0-14 days, 3 months, 6 months, 1 year, and 2 years post-surgery to monitor AVF condition and sounds. During the study, participants will be assessed through imaging and sound analysis to measure blood flow patterns and their relationship with AVF vibrations and sounds. Researchers will track the correlation between blood flow disturbances and sound features at each visit. The study will measure how well sound analysis can indicate AVF health over two years, helping develop new, non-invasive monitoring tools. Safety and health status will be regularly checked throughout the follow-up period.

CONDITIONS

Brief Title

Blood Flow Conditions and Sounds in AVFs

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide informed consent before any study procedures
  • Be female or male aged between 18 and 90 years
  • Be on hemodialysis treatment needing a new vascular access or be in a pre-dialysis program for end-stage renal disease
  • Have surgical creation of an autogenous arteriovenous fistula planned in the forearm
Not Eligible

You will not qualify if you...

  • Have contraindications for creating an autogenous arteriovenous fistula
  • Have a previously failed arteriovenous fistula in the arm planned for surgery
  • Have contraindications to MRI such as pregnancy, claustrophobia, or MRI-incompatible devices
  • Be currently on hemodialysis with a catheter or graft
  • Be undergoing peritoneal dialysis
  • Have a life expectancy of less than 2 years

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (screening and enrollment visit)

Surgery

Duration - Day 0

Participants undergo surgery for vascular access (arteriovenous fistula creation).

1 visit (in-person surgery visit)

Long-term Monitoring

Duration - Up to 2 years after surgery

Participants are monitored with diagnostic tests and assessments to study blood flow conditions and sounds in the arteriovenous fistula.

Visits at day 14, 3 months, 6 months, 1 year, and 2 years after surgery

Trial Site Locations

Total: 1 location

1

A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi

Bergamo, Bergamo, Italy, 20147

Actively Recruiting

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Research Team

M

Michela Bozzetto

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Disturbed flow in radial-cephalic arteriovenous fistulae for haemodialysis: low and oscillating shear stress locates the sites of stenosis.

Bogdan Ene-Iordache, Andrea Remuzzi

https://pubmed.ncbi.nlm.nih.gov/21771751