UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060862 |
|---|---|
| Receipt number | R000069643 |
| Scientific Title | Effect of Quantity of Blood flow in Arteriovenous Fistula for Hemodialysis on Right Heart Load Findings |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/03/06 23:38:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Quantity of Blood flow in Arteriovenous Fistula for Hemodialysis on Right Heart Load Findings
Acronym
Effect of Quantity of Blood flow in Arteriovenous Fistula for Hemodialysis on Right Heart Load Findings
Scientific Title
Effect of Quantity of Blood flow in Arteriovenous Fistula for Hemodialysis on Right Heart Load Findings
Scientific Title:Acronym
Effect of Quantity of Blood flow in Arteriovenous Fistula for Hemodialysis on Right Heart Load Findings
Region
| Japan |
Condition
Condition
Congestive heart failure in hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of quantity of blood flow (QB) through arteriovenous fistulas (AVFs) for hemodialysis on the development of congestive heart failure and findings of right ventricular overload, and to re-examine the risk of heart failure associated with QB of AVFs.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of congestive heart failure of NYHA Class II or higher
Key secondary outcomes
Changes in Right Ventricular Load Findings on Echocardiography
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases undergoing continuous hemodialysis management at our hospital during the period from April 1, 2020, to March 31, 2025
Key exclusion criteria
1) Cases not maintaining an AVF as vascular access
2) Cases where follow-up could not be confirmed due to death or failure to attend follow-up appointments
3) Other individuals deemed ineligible by the physician's judgment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Okada |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
350-0451
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama Prefecture
TEL
049-276-1611
tatkondo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Kondo |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
350-0451
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama Prefecture
TEL
049-276-1611
Homepage URL
tatkondo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital Clinical Research Center
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama Prefecture
Tel
049-276-1354
hirb@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study targeted hemodialysis patients who underwent initiation of dialysis at our hospital and received maintenance dialysis management for over five years. We measured brachial artery blood flow at five years post-initiation using pulse Doppler ultrasound and evaluated its correlation with the incidence of congestive heart failure during the follow-up period. Additionally, we compared right ventricular load findings on transthoracic echocardiography at initiation with those at five years post-initiation.
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069643
