UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042656 |
|---|---|
| Receipt number | R000048662 |
| Scientific Title | Effect on ARNI on renal function and body fluid volume |
| Date of disclosure of the study information | 2020/12/05 |
| Last modified on | 2022/08/15 19:41:06 |
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Basic information
Public title
Effect on ARNI on renal function and body fluid volume
Acronym
Effect on ARNI on renal function and body fluid volume
Scientific Title
Effect on ARNI on renal function and body fluid volume
Scientific Title:Acronym
Effect on ARNI on renal function and body fluid volume
Region
| Japan |
Condition
Condition
Congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect on ARNI on renal function and body fluid volume
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urine volume from day 0 to day 5.
Key secondary outcomes
Transition of creatinine, eGFR, body weight, NAG and NT-proBNP from day 0 to day 5.
The incidence of death and rehospitalization for heart failure within 60 days.
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
(1)Patients 20 years of age or older were eligible for inclusion in trial if they had left ventricular ejection fraction of 40% or less and had primary diagnosis of congestive heart failure
(2)Stable cardiohemodynamics(sBP >= 90 mmHg)
(3)Not in use inotrope
Key exclusion criteria
(1)contraindication in packge insert
(2)Cardiogenic shock
(3)ACS
(4)Pregnancy
(5)A patient who started clinical trials
(6)A patient who couldn't attend a hospital
(7)A patient improper to this clinical trial according to the decision of a principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Horiuchi |
Organization
Mitsui Memorial Hospital
Division name
Division of Cardiology
Zip code
101-8643
Address
Kanda-Izumicho 1, Chiyoda-ku, Tokyo
TEL
03-3862-9111
yooouyou@gmail.com
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Setoguchi |
Organization
Mitsui Memorial Hospital
Division name
Division of Cardiology
Zip code
101-8643
Address
Kanda-Izumicho 1, Chiyoda-ku, Tokyo
TEL
03-3862-9111
Homepage URL
naoto.stgc@gmail.com
Sponsor or person
Institute
Mitsui Memorial hospital
Institute
Department
Personal name
Funding Source
Organization
Mitsui Memorial Hospital
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
Mitsui Memorial Hospital
Address
Kanda-Izumicho 1, Chiyoda-ku, Tokyo
Tel
03-3862-9111
c-uno@mitsuihosp.or.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
| 2020 | Year | 12 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 01 | Day |
Other
Other related information
prospective observational study
Management information
Registered date
| 2020 | Year | 12 | Month | 04 | Day |
Last modified on
| 2022 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048662
