End Stage Renal DiseaseAPOLLONCT06411353
Blood Flow Conditions and Sounds in AVFs
A study testing MRI acquisition and US examination in people with End Stage Renal Disease, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- MRI acquisition and US examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi
Bergamo, Bergamo, 20147
Piero Ruggenenti, MD, pruggenenti@hpg23.it
About this study
Official title: The Relationship Between Blood Flow Conditions and Sounds in Arteriovenous Fistulae for Hemodialysis
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.
Read the detailed description
The native arteriovenous fistula (AVF) is the lifeline for patients on hemodialysis treatment, but it is still affected by high non-maturation and early failure rates, requiring in most of the cases, the creation of a new vascular access.
Despite the exact mechanism underlying stenosis development and consequent AVF failure remains tentative, there is a general consensus that hemodynamic conditions play a key role. The hemodynamic conditions can be studied using computational fluid dynamic simulations (CFD), advanced computational techniques that allow to simulate blood flowing in virtual 3D models generated from medical images. The current gold standard in the clinical studies with CFD is to obtain reliable 3D AVF models from non-contrast enhanced MRI and our group developed a novel MRI protocol for this purpose. However, recent studies performed by other groups suggest that US technique can also provide accurate and reliable models and the hit on the market, and the tUS Piur Device, which was recently made available to the investigators' research group, offers new avenues for non-invasive and inexpensive 3D patient-specific AVF model generation. Previous computational fluid dynamics investigations inside patient-specific AVF models conducted by the investigators revealed transitional turbulent-like flow in the vein. In particular, the investigators evaluated the venous surface areas occupied by high values of the Oscillatory Shear Index (OSI), a well-accepted hemodynamic metric for the identification of disturbed flow conditions, and they found that wide areas of the venous segment of AVFs are characterized by OSI > 0.1. More recently, by using fluid structure interaction simulations, the investigators have shown that such turbulent-like blood flow conditions cause the venous wall to vibrate at high frequencies and that wall vibrations phenotypically collocate with typical regions of stenosis formation. The investigators' hypothesis is that flow-induced vibrations are transmitted to the skin surface of the patient and then result in those palpable thrills and audible bruits that, over the years, nurses and nephrologists got used to qualitatively evaluate using their stethoscopes. However, up to now sound evaluation has only been qualitative and therefore very subjective, but it may provide a strong indication of aberrant hemodynamic conditions and could have a potential as a non-invasive and unexpensive surveillance method.
Therefore, studies aimed at clarifying the relationship between the blood flow conditions and the AVF sound will help advancing the knowledge in the field, providing indications on the role of hemodynamics in AVF failure and bringing out novel methods such as sound analysis for AVF surveillance.
- Conditions
- End Stage Renal Disease
- Being tested
- MRI acquisition, US examination
- Keywords
- Arteriovenous fistula, Computational modelling, Hemodynamic conditions, Stenosis
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI acquisitionDiagnostic test
Non-contrast enhanced acquisitions will be performed using a whole-body MRI scanner operating at 1.5 Tesla or greater.
US examinationDiagnostic test
A complete assessment of the AVF vessels is performed using advanced 3D US procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: MRI acquisition; Diagnostic Test: US examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At each established study visit (i.e., at day 14, at months 3, 6, 12, 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Mar 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Zerbi, MD, Principal investigator, ASST Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411353
- Sponsor's protocol ID
- APOLLO
- Acronym
- APOLLO
- Status last verified
- Aug 2025
- First submitted
- 8 May 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19002516Ene-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.
PubMed 21771751Santoro 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.
PubMed 25045278Bozzetto 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.
PubMed 28288599
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Blood Flow Conditions and Sounds in Arteriovenous Fistulae for Hemodialysis
- ClinicalTrials.gov ID
- NCT06411353
- Acronym / sponsor ID
- APOLLO / APOLLO
- Conditions
- End Stage Renal Disease
- Keywords
- Arteriovenous fistula, Computational modelling, Hemodynamic conditions, Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The native arteriovenous fistula (AVF) is the lifeline for patients on hemodialysis treatment, but it is still affected by high non-maturation and early failure rates, requiring in most of the cases, the creation of a new vascular access.
Despite the exact mechanism underlying stenosis development and consequent AVF failure remains tentative, there is a general consensus that hemodynamic conditions play a key role. The hemodynamic conditions can be studied using computational fluid dynamic simulations (CFD), advanced computational techniques that allow to simulate blood flowing in virtual 3D models generated from medical images. The current gold standard in the clinical studies with CFD is to obtain reliable 3D AVF models from non-contrast enhanced MRI and our group developed a novel MRI protocol for this purpose. However, recent studies performed by other groups suggest that US technique can also provide accurate and reliable models and the hit on the market, and the tUS Piur Device, which was recently made available to the investigators' research group, offers new avenues for non-invasive and inexpensive 3D patient-specific AVF model generation. Previous computational fluid dynamics investigations inside patient-specific AVF models conducted by the investigators revealed transitional turbulent-like flow in the vein. In particular, the investigators evaluated the venous surface areas occupied by high values of the Oscillatory Shear Index (OSI), a well-accepted hemodynamic metric for the identification of disturbed flow conditions, and they found that wide areas of the venous segment of AVFs are characterized by OSI > 0.1. More recently, by using fluid structure interaction simulations, the investigators have shown that such turbulent-like blood flow conditions cause the venous wall to vibrate at high frequencies and that wall vibrations phenotypically collocate with typical regions of stenosis formation. The investigators' hypothesis is that flow-induced vibrations are transmitted to the skin surface of the patient and then result in those palpable thrills and audible bruits that, over the years, nurses and nephrologists got used to qualitatively evaluate using their stethoscopes. However, up to now sound evaluation has only been qualitative and therefore very subjective, but it may provide a strong indication of aberrant hemodynamic conditions and could have a potential as a non-invasive and unexpensive surveillance method.
Therefore, studies aimed at clarifying the relationship between the blood flow conditions and the AVF sound will help advancing the knowledge in the field, providing indications on the role of hemodynamics in AVF failure and bringing out novel methods such as sound analysis for AVF surveillance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Diagnostic Test: MRI acquisition, Diagnostic Test: US examinationPatients 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI acquisitionNon-contrast enhanced acquisitions will be performed using a whole-body MRI scanner operating at 1.5 Tesla or greater. | Diagnostic test | Patients |
| US examinationA complete assessment of the AVF vessels is performed using advanced 3D US procedures. | Diagnostic test | Patients |
Primary outcome
Correlation coefficient between LHPR and the vein's surface area with OSI > 0.1
Time frame: At each established study visit (i.e., at day 14, at months 3, 6, 12, 24)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 19002516Antiga 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.
- Background: PubMed 21771751Ene-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.
- Background: PubMed 25045278Santoro 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.
- Background: PubMed 28288599Bozzetto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simona Zerbi, MD principal investigator
ASST Papa Giovanni XXIII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI acquisition and US examination in people with End Stage Renal Disease, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michela Bozzetto (+3903545351, michela.bozzetto@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between LHPR and the vein's surface area with OSI > 0.1 (time frame: At each established study visit (i.e., at day 14, at months 3, 6, 12, 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06411353, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.