UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058674 |
|---|---|
| Receipt number | R000067092 |
| Scientific Title | Impact of Resting Full-cycle Ratio on Clinical Outcomes in Patients on Hemodialysis |
| Date of disclosure of the study information | 2025/08/04 |
| Last modified on | 2025/08/02 00:58:07 |
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Basic information
Public title
Impact of Resting Full-cycle Ratio on Clinical Outcomes in Patients on Hemodialysis
Acronym
RFR-HD study
Scientific Title
Impact of Resting Full-cycle Ratio on Clinical Outcomes in Patients on Hemodialysis
Scientific Title:Acronym
RFR-HD study
Region
| Japan |
Condition
Condition
Coronary artery disease on hemodialysis
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate prognostic impact of resting full-cycle ratio (RFR) on clinical outcomes in patients on hemodialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite of cardiac death, target vessel myocardial infarction, and clinical driven target vessel revascularization
Key secondary outcomes
Individual outcomes of the primary end point. all-cause death, non-target vessel myocardial infarction, and clinical driven non-target vessel revascularization.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with age 20 years or older at the time of enrollment
Patients on hemodialysis
Patients with or suspected coronary artery disease
Patients with RFR measurement
Key exclusion criteria
Patients with acute myocardial infarction
Patients with hemodynamic instability
Patients with decompensated heart failure
Patients treated by coronary revascularization for target vessel based on RFR
Patients with RFR measurement for coronary artery bypass graft
Patients with a life expectancy of 12 months or less
Others who are judged to be inappropriate as research subjects by the principal investigator
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Koga |
Organization
Juntendo University Nerima Hospital
Division name
Department of Cardiology
Zip code
177-8521
Address
3-1-10, Takanodai, Nerima-ku, Tokyo
TEL
03-5923-3111
kogase@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Koga |
Organization
Juntendo University Nerima Hospital
Division name
Department of Cardiology
Zip code
177-8521
Address
3-1-10, Takanodai, Nerima-ku, Tokyo
TEL
03-5923-3111
Homepage URL
kogase@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
hongo-rinri@juntendo.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
| 2025 | Year | 08 | Month | 04 | 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
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | 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
Patients on hemodialysis who underwent RFR measurement for coronary artery lesions between August 1, 2018, and March 31, 2025,were targeted.
Management information
Registered date
| 2025 | Year | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067092
