UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008028 |
|---|---|
| Receipt number | R000009453 |
| Scientific Title | A Clinical Study on Hemodynamic Changes by the Low Dose of Tolvaptan in Heart Failure Patients |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2012/05/26 11:57:55 |
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Basic information
Public title
A Clinical Study on Hemodynamic Changes by the Low Dose of Tolvaptan in Heart Failure Patients
Acronym
A Study on Hemodynamic Changes by the Low Dose of Tolvaptan
Scientific Title
A Clinical Study on Hemodynamic Changes by the Low Dose of Tolvaptan in Heart Failure Patients
Scientific Title:Acronym
A Study on Hemodynamic Changes by the Low Dose of Tolvaptan
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation on the Safety & Efficacy of Low dose of Tolvaptan to the Patients with Congestive Heart Failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic Changes, Change of Body Weight
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
Tolvaptan is administered from the dose of 3.75mg/day. The dose of tolvaptan can be stepwise increased to 7.5mg/day, then 15mg/day.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with heart failure of Nohria/Steavenson B & C who need Swan-Ganz catheter for hemodynamic monitoring.
Key exclusion criteria
1) the patient's s-Na >147mEq/L at the administration of tolvaptan
2) the patients showing shock
3) the patient's creatinine >3.0mg/dL
4) the patient showing allergy to tolvaptan
5) pregnant patient
6) the patient regarded as inappropriate for this clinical study by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Nunoda, M.D., Ph.D. |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Cardiovascular Division
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo 116-8567
TEL
03-3810-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Nunoda. M.D., Ph.D. |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Cardiovascular Division
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo 116-8567
TEL
03-3810-1111
Homepage URL
nunodagm@dnh.twmu.ac.jp
Sponsor or person
Institute
Institutional Review Board, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University Medical Center East
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
東京女子医科大学東医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | 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
| 2012 | Year | 05 | Month | 26 | Day |
Last modified on
| 2012 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009453
