UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028039 |
|---|---|
| Receipt number | R000032102 |
| Scientific Title | Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure. |
| Date of disclosure of the study information | 2017/07/03 |
| Last modified on | 2018/09/25 19:43:57 |
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Basic information
Public title
Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure.
Acronym
Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure.
Scientific Title
Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure.
Scientific Title:Acronym
Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure.
Region
| Japan |
Condition
Condition
Acute decompensated heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Changes in circulating plasma volume during Tolvaptan combined use in Acute decompensated heart failure in the elderly.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in circulating plasma volume by IVC.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Conventional therapy group
Interventions/Control_2
Tolvaptan add-on therapy 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
| 76 | 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.age 76 over
4.Partients hospitalized for over time visits
Key exclusion criteria
1.Under 75
2.Hypersensitivity for Tolvaptan or Mozavaptan.
3.Anuria
4.Insensitivity to thurst of difficulty in water in take.
5.Patients who already have tolvaptan at entry.
6.Severe coronary arterydisease and cerebrovascular disease.
7.Severe renal failure
8.Hypernatremia(serum Na>146mEq/L)and(serum Na<125mEq/L).
9.Hyperkalemia(serum K>5.5mEq/L)and(serum K<3.0mEq/L).
10.Chronic hepatitis Liver dysfunction(pharmacological etc.).
11.Hepatic encephalopathy.
12.Any conditions inappropriate to this trial deemed by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Ashihara |
Organization
Shinshu University Hospital
Division name
Second Department of Internalmedicine
Zip code
Address
3-1-1,Asahi,Matsumoto.Nagano.Japan
TEL
0263-37-2634
asha_trial@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Takizawa |
Organization
Iiyama redcross hospital
Division name
Division of pharmacy
Zip code
Address
Iiyama226-1,Iiyama.Nagano.Japan
TEL
0269-62-4195
Homepage URL
asha_trial@yahoo.co.jp
Sponsor or person
Institute
Iiyama redcross 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
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
| 2017 | Year | 07 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 28 | 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
| 2017 | Year | 07 | Month | 02 | Day |
Last modified on
| 2018 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032102
