UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052905 |
|---|---|
| Receipt number | R000060363 |
| Scientific Title | Verification of the cardioprotective effect of ARNI on hemodialysis patients with heart disease |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2024/12/08 16:42:54 |
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Basic information
Public title
Verification of the cardioprotective effect of ARNI on hemodialysis patients with heart disease
Acronym
Verification of the cardioprotective effect of ARNI on hemodialysis patients with heart disease
Scientific Title
Verification of the cardioprotective effect of ARNI on hemodialysis patients with heart disease
Scientific Title:Acronym
Verification of the cardioprotective effect of ARNI on hemodialysis patients with heart disease
Region
| Japan |
Condition
Condition
Hemodialysis patients with diagnosed cardiac disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on cardiac function of switching from ARB/ACE to ARNI or starting a new one in hemodialysis patients with diagnosed cardiac disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare changes in cardiac function in the ARNI administration group before and 12 months after initiation of ARNI with the control group.
Key secondary outcomes
Changes in NTproBNP, HANP, and blood pressure before starting ARNI, 1 month, 3 months, 6 months, and 12 months after starting ARNI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Start with ARNI 50mg, 2 tablets a day after breakfast and dinner, and increase to a maximum of 400mg depending on tolerability for 1 year.
Interventions/Control_2
ARNI non-administration group
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatient maintenance dialysis patients with heart disease who are attending our hospital as an outpatient and have consented to take ARNI orally.
Key exclusion criteria
Patients who have difficulty undergoing dialysis due to low blood pressure, patients with dementia, and patients who were unable to consent.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Fujiwara |
Organization
Inoue Hospital
Division name
Medical department
Zip code
5640053
Address
16-17 Enokicho, Suita City
TEL
0663858651
fujiwara.yuuko@aijinkai-group.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Fujiwara |
Organization
Inoue Hospital
Division name
Medical department
Zip code
5640053
Address
16-17 Enokicho, Suita City
TEL
0663858651
Homepage URL
fujiwara.yuuko@aijinkai-group.com
Sponsor or person
Institute
Inoue Hospital
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Inoue Hospital
Address
16-17 Enokicho, Suita City
Tel
0663858651
nakanishi.naho@aijinkai-group.com
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
| 2023 | Year | 11 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060363
