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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018717
Receipt No. 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

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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
Email 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
Email aziro-youichi@yokohamamc.jp

Sponsor
Institute National Hospital Organization Yokohama Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018915

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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