RecruitingNot Applicable

Blood Flow Conditions and Sounds in AVFs

Italy15 participantsStarted 2025-03-01

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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.

What they're measuring

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

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

Trial details

NCT IDNCT06411353

SponsorMario Negri Institute for Pharmacological Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02

Contact for this trial

Michela Bozzetto

+3903545351 michela.bozzetto@marionegri.it

View on ClinicalTrials.gov More End Stage Renal Disease trials