How blood flow and sounds relate in arteriovenous fistulas
The Relationship Between Blood Flow Conditions and Sounds in Arteriovenous Fistulae for Hemodialysis
This study will test whether MRI and ultrasound recordings of blood flow and the sounds from an AVF can help predict fistula problems in adults with end-stage renal disease who need a new forearm access.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Mario Negri Institute for Pharmacological Research Academic / other |
| Locations | 1 site (Bergamo, Bergamo) |
| Trial ID | NCT06411353 on ClinicalTrials.gov |
What this trial studies
This is a prospective non-pharmacological interventional study enrolling adults with end-stage renal disease who require creation of an autogenous forearm arteriovenous fistula. Participants will undergo non-contrast MRI and ultrasound (including a tUS Piur device) to generate patient-specific 3D AVF models and recordings of AVF sounds. Computational fluid dynamics will be used on the 3D models to characterize hemodynamic conditions such as oscillatory shear index and turbulent-like flow, which will be compared with recorded sounds and clinical outcomes. The goal is to determine whether noninvasive imaging and acoustics can predict sites at risk for stenosis or early AVF failure.
Who should consider this trial
Good fit: Adults aged 18–90 with end-stage renal disease who need a new autogenous forearm arteriovenous fistula and can undergo MRI and ultrasound are ideal candidates.
Not a fit: Patients with MRI contraindications, those already dialyzing via catheter or graft, those on peritoneal dialysis, individuals with a prior failed AVF in the same arm, or those with life expectancy under two years are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could enable earlier, noninvasive identification of AVFs at risk for stenosis or failure, allowing timely interventions to preserve vascular access.
How similar studies have performed: Previous CFD studies using MRI-derived AVF models have identified hemodynamic patterns linked to stenosis and early failure, and recent work suggests ultrasound-based 3D modeling is feasible, but combining sound analysis with CFD for prediction remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Contraindications for the creation of an autogenous AVF. * 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. * 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.
Where this trial is running
Bergamo, Bergamo
- A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi — Bergamo, Bergamo, Italy (Recruiting)
Study contacts
- Principal investigator: Simona Zerbi, MD — ASST Papa Giovanni XXIII
- Study coordinator: Michela Bozzetto
- Email: michela.bozzetto@marionegri.it
- Phone: +3903545351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.