Multiparametric MRI for Assessment of Changes of Renal Hemodynamics After Fistula Closure in Kidney Transplant Patients

NCT05015231 | Recruiting

• 1 other identifier: 2021-00474
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of changes of renal hemodynamics by multiparametric MRI after closure of AVF access.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

• Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access

  Assessing changes in renal perfusion

  evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure

• Assessment of changes in renal hemodynamics by multiparametric MRI after closure of AVF access

  Assessing changes in renal oxygenation

  evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure

Secondary Outcomes (1)

• Correlation between AVF access flow and changes as assessed during pneumatic fistula compression with changes in renal hemodynamics after fistula closure

  evaluation of short term changes within 2 weeks after fistula closure and longterm changes 6 months after fistula closure

Interventions

Echocardiography and MRI DIAGNOSTIC_TEST

Echocardiography and renal MRI before and after fistula closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients with a functioning graft and a patent hemodialysis fistula

You may qualify if:

• Written informed consent
• Age \> 18 years
• Patients wishing to close the fistula and planned for surgical fistula closure
• eGFR CKD EPI ≥ 45 ml/min/1.73m2 at one year post transplantation
• Stable eGFR within the past 6 months
• Controlled blood pressure

You may not qualify if:

• Kidney Transplantation \< 12 months before fistula closure
• Proteinuria \> 500mg/d
• Presence of donor specific antibodies
• Rejection within the past 6 months
• BK virus replication within the past 3 months
• Cardiac pacemaker, which is not compatible with MRI
• Claustrophobia

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Interventions

Echocardiography; Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Tomography

Study Officials

• Thomas Müller, Professor

  University Hospital Zurich, Nephrology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Müller, Professor

CONTACT

0041 (0)44 255 11 11; thomas.müller@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 20, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)