UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018081 |
|---|---|
| Receipt number | R000020931 |
| Scientific Title | Tolvaptan and Conventional Treatment for Acute Decompensated Heart Failure |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2015/06/25 10:50:28 |
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Basic information
Public title
Tolvaptan and Conventional Treatment for Acute Decompensated Heart Failure
Acronym
Tolvaptan and Conventional Treatment for Acute Decompensated Heart Failure
Scientific Title
Tolvaptan and Conventional Treatment for Acute Decompensated Heart Failure
Scientific Title:Acronym
Tolvaptan and Conventional Treatment for Acute Decompensated Heart Failure
Region
| Japan |
Condition
Condition
Acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of adding Tolvaptan in acute decompensated heart failure patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Defined length of hospital stay
Occurrence rate of worsening renal function
Key secondary outcomes
Event rate (cardiac death, readmission for heart failure)
Urinary volume
Dosage of Furosemide
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Tolvaptan within 24 hours from admission
Attending physician determine the dose and the duration of administration.
Interventions/Control_2
Dosing up Furosemide within 24 hours from admission
Attending physician determine the dose and the duration of administration.
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. Acute decompensated heart failure patients diagnosed by Framingham criteria
2. Patients who are able to take oral medications
3. Serum sodium < 146 mEq/L at allocation
4. Patients who are able to provide consent
Key exclusion criteria
1. Patients with hypersensitivity to Tolvaptan and the analogous compounds
2. Hemodialysis
3. Disability to appeal thirsty
4. Serum sodium > 145 mEq/L at allocation
5. Pregnancy
6. Acute coronary syndrome
7. Patients who attending physicians consider to be inappropriate due to other reasons mentioned above
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kimura |
Organization
Shinshu University
Nagano Matsushiro General Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
Asahi3-1-1, Matsumoto-shi, Nagano, Japan
TEL
0263-37-3486
kaz_kimura@shishu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kimura |
Organization
Shinshu University
Division name
Department of Cardiovascular Medicine
Zip code
Address
Asahi 3-1-1, Matsumoto-shi, Nagano, Japan
TEL
0263-37-3486
Homepage URL
kaz_kimura@shishu-u.ac.jp
Sponsor or person
Institute
Nagano Matsushiro General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Shinshu University
Name of secondary funder(s)
None
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
長野松代総合病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2015 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020931
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
