UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014441 |
|---|---|
| Receipt number | R000016573 |
| Scientific Title | The dosage, timing and duration of tolvaptan administration in Patients Hospitalized for Acute Decompensated Heart Failure |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2022/12/17 19:35:22 |
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Basic information
Public title
The dosage, timing and duration of tolvaptan administration in Patients
Hospitalized for Acute Decompensated Heart Failure
Acronym
The dosage, timing and duration of tolvaptan administration
Scientific Title
The dosage, timing and duration of tolvaptan administration in Patients
Hospitalized for Acute Decompensated Heart Failure
Scientific Title:Acronym
The dosage, timing and duration of tolvaptan administration
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to determine the relationship between the dosage, timing, duration of tolvaptan administration and clinical outcome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Improvement of heart failure, duration of hospitalization, death
Key secondary outcomes
Change of urine volume, vital signs, electrolytes, renal function, costs of diuretics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The early group receives tolvaptan (5-7 days) within 2 days of hospital admission and the late group receives tolvaptan(5-7 days) from day 5 or 6 day of hospitalization
Interventions/Control_2
In case of re-admission within 6 months, the patient will be treated with continuing use of tolvaptan. we compatere first hospitalisation with second hospitalisation
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
Patients hospitalized with heart failure
Key exclusion criteria
Contraindication of usage of tolvaptan
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tanaka |
| Middle name | |
| Last name | Nobukiyo |
Organization
Ichinomiya Nishi Hospital
Division name
Department of Cardiovascular Medicine
Zip code
4940001
Address
Ichinomiya, Japan
TEL
0586-48-0077
nobukiyo282000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tanaka |
| Middle name | |
| Last name | Nobukiyo |
Organization
Ichinomiya Nishi Hospital
Division name
Department of Cardiovascular Medicine
Zip code
4940001
Address
Ichinomiya, Japan
TEL
0586-48-0077
Homepage URL
nobukiyo282000@yahoo.co.jp
Sponsor or person
Institute
Ichinomiya Nishi Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Ichinomiya Nishi Hospital
Address
Kaimei Hira
Tel
0586480077
nobukiyo282000@yahoo.co.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
| 2014 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2014 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016573
