Blood Flow Conditions and Sounds in AVFs

NCT06411353 | Recruiting

• 1 other identifier: APOLLO
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease

Keywords

Arteriovenous fistula; Computational modelling; Hemodynamic conditions; Stenosis

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient between LHPR and the vein's surface area with OSI > 0.1

  LHPR: ratio between the amplitude of maximum peak in the range of low-frequency (100-250 Hz) and the amplitude of the maximum peak at high frequency (500-750 Hz). OSI: oscillatory shear index, common metric for disturbed blood flow.

  At each established study visit (i.e., at day 14, at months 3, 6, 12, 24)

Study Arms (1)

Patients

EXPERIMENTAL

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).

Diagnostic Test: MRI acquisition; Diagnostic Test: US examination

Interventions

MRI acquisition DIAGNOSTIC_TEST

Non-contrast enhanced acquisitions will be performed using a whole-body MRI scanner operating at 1.5 Tesla or greater.

Patients

US examination DIAGNOSTIC_TEST

A complete assessment of the AVF vessels is performed using advanced 3D US procedures.

Patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

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

Bergamo, Bergamo, 20147, Italy

RECRUITING

Related Publications (4)

• Antiga L, Piccinelli M, Botti L, Ene-Iordache B, Remuzzi A, Steinman DA. An image-based modeling framework for patient-specific computational hemodynamics. Med Biol Eng Comput. 2008 Nov;46(11):1097-112. doi: 10.1007/s11517-008-0420-1. Epub 2008 Nov 11.

  PMID: 19002516 BACKGROUND

• Ene-Iordache B, Remuzzi A. Disturbed flow in radial-cephalic arteriovenous fistulae for haemodialysis: low and oscillating shear stress locates the sites of stenosis. Nephrol Dial Transplant. 2012 Jan;27(1):358-68. doi: 10.1093/ndt/gfr342. Epub 2011 Jul 18.

  PMID: 21771751 BACKGROUND

• Santoro D, Benedetto F, Mondello P, Pipito N, Barilla D, Spinelli F, Ricciardi CA, Cernaro V, Buemi M. Vascular access for hemodialysis: current perspectives. Int J Nephrol Renovasc Dis. 2014 Jul 8;7:281-94. doi: 10.2147/IJNRD.S46643. eCollection 2014.

  PMID: 25045278 BACKGROUND

• Bozzetto M, Rota S, Vigo V, Casucci F, Lomonte C, Morale W, Senatore M, Tazza L, Lodi M, Remuzzi G, Remuzzi A. Clinical use of computational modeling for surgical planning of arteriovenous fistula for hemodialysis. BMC Med Inform Decis Mak. 2017 Mar 14;17(1):26. doi: 10.1186/s12911-017-0420-x.

  PMID: 28288599 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Officials

• Simona Zerbi, MD

  ASST Papa Giovanni XXIII

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michela Bozzetto

CONTACT

+3903545351; michela.bozzetto@marionegri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)