Blood Flow Conditions and Sounds in AVFs
Recruiting · NCT06411353 · Interventional (participants receive a specific treatment) · Lead sponsor: Mario Negri Institute for Pharmacological Research
View the official record on ClinicalTrials.gov →Interventions studied
MRI acquisitionUS examination
What this trial is about
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 take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi - Bergamo, Bergamo, Italy