UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012170 |
|---|---|
| Receipt number | R000014227 |
| Scientific Title | Effect of Tolvaptan on hemodynamic of congestive heart failure. |
| Date of disclosure of the study information | 2013/10/31 |
| Last modified on | 2021/11/05 09:22:58 |
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Basic information
Public title
Effect of Tolvaptan on hemodynamic of congestive heart failure.
Acronym
Effect of Tolvaptan on hemodynamic of congestive heart failure.
Scientific Title
Effect of Tolvaptan on hemodynamic of congestive heart failure.
Scientific Title:Acronym
Effect of Tolvaptan on hemodynamic of congestive heart failure.
Region
| Japan |
Condition
Condition
Congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study si to evaluate the efficacy of Tolvaptan on hemodynamic of congestive heart failure patients. The hemodynamic is evaluated by Swan-Gantz catheter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hemodynamic
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Tolvaptan group
Tolvaptan 7.5mg/day and Fulosemide 10mg/day are administered for 7days. If not effective, Tolvaptan is administered up to 15mg/day.
Interventions/Control_2
Control group
Fulosemide in administered for 7days.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who diagnosed Congestive heart failure
2. NYHA class III or IV
3. Patients who are admitted to our hospital.
Key exclusion criteria
1. Hypernatremia (serum sodium >= 146mEq/L)
2. Hyponatremia (serum sodium < 125mEq/L)
3. Hyperkalemia (serum potassium >= 5.1mEq/L)
4. Anuric patients
5. Renal insufficiency (serum creatinine > 4.0mEq/L
6. Systolic blood pressure < 90mmHg
7. Severe coronary artery disease or cerebrovascular disease
8. Hypertrophic obstructive cardiomyopathy or severe valvular heart disease
9. Patients who cannot declare thirst or cannot drink water
10. Expectant mother
11. Patients who implanted pace maker, ICD, CRT-D or mechanical valves
12. Intubation
13. Hypersensitivity for Tolvaptan or Mozavaptan
14. Inappropriate patients judged by the physician in charge
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihide Fujimoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba city Chiba 260-8677 Japan
TEL
043-226-2340
LapisLazurite@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keishi Ishikawa |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba city Chiba 260-8677 Japan
TEL
043-226-2340
Homepage URL
LapisLazurite@hotmail.com
Sponsor or person
Institute
Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
YES
Study ID_1
G23045
Org. issuing International ID_1
Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 31 | 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
| 2011 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 30 | Day |
Last modified on
| 2021 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014227
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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