UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013091 |
|---|---|
| Receipt number | R000015276 |
| Scientific Title | Oral medication using Tolvaptan for ADL of patients with acute congestive heart failure |
| Date of disclosure of the study information | 2014/02/07 |
| Last modified on | 2017/02/13 23:11:07 |
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Basic information
Public title
Oral medication using Tolvaptan for ADL of patients with acute congestive heart failure
Acronym
Oral medication using Tolvaptan for ADL of patients with acute congestive heart failure
Scientific Title
Oral medication using Tolvaptan for ADL of patients with acute congestive heart failure
Scientific Title:Acronym
Oral medication using Tolvaptan for ADL of patients with acute congestive heart failure
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether oral medication using Tolvaptan for hospitalized patients with acute heart failure prevents impairment in ADL compared with conventional intravenous infusion treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
activity of daily living (ADL), quality of life (QOL)
Key secondary outcomes
Duration of hospitalization, place of discharge, cost
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
conventional intravenous treatment (without Tolvaptan)
Interventions/Control_2
oral treatment including Tolvaptan (avoiding continuous intravenous therapy)
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
agreement by patients
beyond 20 years old
diagnosed with acute congestive heart failure
Key exclusion criteria
acute myocardial infarction
severe respiratory failure (PaO2<60Torr, and/or SPO2<90% on oxygen administration)
shock vital (sBP<90mmHg)
serum sodium >146
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Kasao |
Organization
Tokyo Metropolitan Police Hospital
Division name
Department of Cardiology
Zip code
Address
4-22-1, Nakano, Nakano, Tokyo, 164-8541
TEL
+81-3-5343-5611
mu3948@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutaka Ueda |
Organization
Tokyo Metropolitan Police Hospital
Division name
Department of Cardiology
Zip code
Address
4-22-1, Nakano, Nakano, Tokyo, 164-8541
TEL
+81-3-5343-5611
Homepage URL
ueda-cib@umin.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Police 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
Address
Tel
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 | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 06 | Day |
Last modified on
| 2017 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015276
