UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010196 |
|---|---|
| Receipt number | R000011944 |
| Scientific Title | Study of the safety and efficacy of tolvaptan for fluid retention symptoms of right heart failure due to pulmonary hypertension |
| Date of disclosure of the study information | 2013/03/10 |
| Last modified on | 2015/09/09 11:09:41 |
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Basic information
Public title
Study of the safety and efficacy of tolvaptan for fluid retention symptoms of right heart failure due to pulmonary hypertension
Acronym
Tolvaptan for right heart failure due to pulmonary hypertension
Scientific Title
Study of the safety and efficacy of tolvaptan for fluid retention symptoms of right heart failure due to pulmonary hypertension
Scientific Title:Acronym
Tolvaptan for right heart failure due to pulmonary hypertension
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe how the administration of tolvaptan improve symptomatic fluid retention in patients with fluid retention symptoms of right heart failure due to pulmonary hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The usage dose of loop diuretics.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of tolvaptan
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) Chronic right heart failure due to pulmonary hypertension
2) Physical findings of fluid retention
3) Loop diuretic administration of furosemide 60mg in a day
4) Written informed consent is obtained
Key exclusion criteria
1) Systolic blood pressure is less than or equal to 70mmHg
2) There is a history of hypersensitivity for similar compounds (such as hydrochloride Mozabaputan) components or tolvaptan
3) Anuria
4) A subject is difficult to feel thirst or water intake
5) Hypernatremia
6) There is a possibility that a subject is pregnant or pregnant women
7) Hepatic coma
8) There is a history of hypersensitivity to sulfonamide derivatives
9) Tolvaptan has been administered from admission to registration
10) Acute coronary syndromes
11) Scheduled to perform coronary angioplasty during follow-up period
12) Physicians and other staff have been deemed inappropriate for registration of this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Tamura |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
TEL
03-5843-6702
Homepage URL
Sponsor or person
Institute
Department of Cardiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Keio University School of Medicine
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://erj.ersjournals.com/content/46/1/283.extract
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
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 09 | Day |
Last modified on
| 2015 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011944
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
