UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018717 |
|---|---|
| Receipt number | R000018915 |
| Scientific Title | Yokohama Heart Failure Investigators:Time Zone Dynamics of Serum Arginine-Vasopressin and Urine Aquaporin-2 on Acute Decompensated Heart Failure in the Patients with Depressed Left Ventricular Function |
| Date of disclosure of the study information | 2015/08/19 |
| Last modified on | 2016/02/03 21:08:18 |
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Basic information
Public title
Yokohama Heart Failure Investigators:Time Zone Dynamics of Serum Arginine-Vasopressin and Urine Aquaporin-2 on Acute Decompensated Heart Failure in the Patients with Depressed Left Ventricular Function
Acronym
T-Dynosaur
Scientific Title
Yokohama Heart Failure Investigators:Time Zone Dynamics of Serum Arginine-Vasopressin and Urine Aquaporin-2 on Acute Decompensated Heart Failure in the Patients with Depressed Left Ventricular Function
Scientific Title:Acronym
T-Dynosaur
Region
| Japan |
Condition
Condition
Acute congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the time-zone difference on diuresis effect of tolvaptan in the patient with acute congestive heart failure measuring serum arginine vasopressine (AVP) concentration and urine aquaporin-2(AQP2)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
urine volume per 6 hours
Key secondary outcomes
Relationship between urine AQP2, serume AVP and diuresis effect of tolvaptan
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tolvaptan morning administering group: Tolvaptan is administered in the morning from the third through fifth in-hospital day (3days)
Interventions/Control_2
tolvaptan before-sleep administering group: Tolvaptan is administered before sleep from the third through fifth in-hospital day (3days)
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) patient older than 20 years old
2) Patient who is treated acute heart failure presenting clinical scenarios 1 and 2 with carperitide under bladder catheterization
3) patient who is planed to administer tolvaptan because of insufficient diuresis only by intravenous injection frosemide
4) patient with chronic kidney disease (eGFR<60ml/min/1.73m2)
5)patient with depressed left ventricular function (left ventricle ejection fraction <55% or left ventricle shortening rate <26%)
6)patient from whom consent for participation in this clinical study was obtained
Key exclusion criteria
1)patient with acute heart failure presenting clinical scenarios 3, 4, and 5
2)patient to whom tolvaptan has already been administered
3)patient to whom continuous intravenous infusion inotropes (catecholamine, phosphodiesterase-3 inhibitors, colforsin daropate hydrochloride, etc) has already been administered or is planned to be administered
4)patient who has received mechanical support (invasive mechanical ventilation, intraaortic balloon pumping, percutaneous cardiopulmonary support, continuation hemofiltration-dialysis, etc.) or is planned to use it
5)patient who presents shock at enrollment
6)Patient with advanced renal dysfunction (eGFR<30ml/min/1.73m2)
7)patient who is judged to be improper by the doctor in charge
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Tsukamoto |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Department of Cardiology
Zip code
Address
3-60-2Harajuku,Totsuka-ku,Yokohama,Kanagawa-ken,245-8575,Japan
TEL
+81-45-851-2621
kei.tsukamoto1129@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Ajiro |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Department of Cardiology
Zip code
Address
3-60-2Harajuku,Totsuka-ku,Yokohama,Kanagawa-ken,245-8575,Japan
TEL
+81-45-851-2621
Homepage URL
aziro-youichi@yokohamamc.jp
Sponsor or person
Institute
National Hospital Organization Yokohama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Devision, National Hospital Organization Yokohama Medical Center
Organization
Division
Category of Funding Organization
Self funding
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
国立病院機構 横浜医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 19 | 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
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | 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
| 2015 | Year | 08 | Month | 19 | Day |
Last modified on
| 2016 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018915
| 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 |
