Taking people in ItalyNo phase

Studying blood flow and sounds in dialysis access fistulas

Compares blood flow and fistula sounds using MRI and ultrasound in adults with kidney failure.

Key facts

Who runs it: Mario Negri Institute for Pharmacological Research
Where: Bergamo, ItalySee the site
Trial code: NCT06411353
Registry title: Blood Flow Conditions and Sounds in AVFs
Status: Recruiting
People taking part: 15 people, planned
Started: 1 Mar 2025
Expected to end: Feb 2028
Type of study: Interventional
Treatments tested: MRI acquisition
US examination
Record updated: 4 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 90 with end-stage kidney disease who need a new blood access for dialysis, to study fistula blood flow and sounds.

Age: 18 to 90 years
Sex: Women and men can join
Disease stage: End-stage kidney disease. People are on haemodialysis and need a new access, or are in a pre-dialysis program. The planned treatment is a fistula made from the person's own vessels in the forearm.
Earlier treatment: People already on haemodialysis through a catheter or a graft cannot join. A fistula that failed before in the same arm is also not allowed.

Main reasons for not taking part

Cannot have a fistula made from their own vessels
A failed fistula before in the same arm chosen for surgery
Cannot have an MRI: pregnancy, claustrophobia, pacemaker or other MRI-incompatible implants
Already on haemodialysis through a catheter or a graft
On peritoneal dialysis, or life expectancy under 2 years

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

Provision of informed consent prior to any study specific procedures
Female and/or male aged between 18 and 90 years
Patients in HD treatment who need a new VA or patients who entered the pre-dialysis program because of ESRD. In all cases, the first-choice treatment is the surgical creation of an autogenous AVF in patient's forearm

Who cannot take part

Presence of a previously failed AVF in the same arm selected for surgery
Patients with contraindications to MRI including: pregnancy, claustrophobia, cardiac pacemakers or other MRI-incompatible prostheses
Contraindications for the creation of an autogenous AVF
Patients already on HD treatment through a catheter or a graft
Patients undergoing peritoneal dialysis
Patients with a life expectancy of less than 2 years

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 90 years old?

Where in Italy

A.O. Papa Giovanni XXIII - U.O. Nefrologia e DialisiBergamo, ItalyContact: Piero Ruggenenti, MDTaking people

About the trial

What the trial wants to find out

This is a prospective non-pharmacological interventional study aimed at investigating the relationship between the blood flow condition and the arteriovenous fistula (AVF) sound, with the ultimate aim of predicting the AVF clinical, in patients with end-stage renal disease (ESRD) who require the creation of a vascular access for extracorporeal circulation.

The group in the trial

PatientsTreatment being tested
Patients will first undergo visit V1 (screening and enrolment). On day 0 they will have the surgery for VA creation (V2) and then the study follow-up visits will take place i.e., between 0 and 14 days, at 3 months, 6 months, 1 year and 2 years after VA surgery (V3-V7).
Treatment: MRI acquisition and US examination