UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021110 |
|---|---|
| Receipt number | R000024120 |
| Scientific Title | Efficacy and safety of administration of Tolvaptan twice daily in hospitalized acute heart failure patients |
| Date of disclosure of the study information | 2016/02/19 |
| Last modified on | 2018/04/21 13:53:06 |
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Basic information
Public title
Efficacy and safety of administration of Tolvaptan twice daily in hospitalized acute heart failure patients
Acronym
Administration of Tolvaptan twice daily in hospitalized acute heart failure patients
Scientific Title
Efficacy and safety of administration of Tolvaptan twice daily in hospitalized acute heart failure patients
Scientific Title:Acronym
Administration of Tolvaptan twice daily in hospitalized acute heart failure patients
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of efficacy and adverse effect of Tolvaptan between administration twice daily and that of once daily in patients with acute heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of congestion scale (7 consecutive days from administration)
Key secondary outcomes
serial change of renal function (7 consecutive days after administration)
urine volume (7 consecutive days after administration)
weight change (7 consecutive days after administration)
serial change of other laboratory markers(7 consecutive days after administration)
prognosis(30-day, 6-month)
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administrations of Tolvaptan once daily at 9 AM (Duration of administration or total dose of Tolvaptan is determined by clinical course)
Interventions/Control_2
Administrations of Tolvaptan twice daily at 9 AM and 3 PM (Duration of administration or total dose of Tolvaptan is determined by clinical course)
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
Hospitalized acute heart failure patients with volume overload
Subjects with NYHA functional classification II-IV
Subjects with Furosemide > 40mg/day
Serum sodium level < 140mEq/L
Agreement with written informed consent
Key exclusion criteria
Subjects with hemodialysis or anuria
Subjects with acute coronary syndrome, pregnancy, malignancy, or previously administration of Tolvaptan
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo Kamiya |
Organization
Japanese Red Cross Nagoya First Hospital
Division name
Department of Cardiology
Zip code
Address
3-35, Michishita-cho, Nakamura-ku, Nagoya city, Aichi, Japan
TEL
052-481-5111
oguricap0909@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsutoshi Oguri |
Organization
Kasugai Municipal Hospital
Division name
Department of Cardiology
Zip code
Address
1-1-1 Takaki-cho, Kasugai Aichi 486-8510, Japan
TEL
0568-57-0057
Homepage URL
oguricap0909@gmail.com
Sponsor or person
Institute
Japanese Red Cross Nagoya First Hospital
Institute
Department
Personal name
Funding Source
Organization
Kasugai Municipal Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kasugai Municipal Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The subjects were assigned to either the once-daily 7.5mg dosing regimen (N=15) or the twice-daily 3.75mg dosing regimen (N=16). The time-course changes in body weight, serum sodium and creatinine levels, systolic blood pressure, daily urine output, and congestion scores were similar between the two groups. In the twice-daily 3.75mg dosing group, the serum sodium levels on days 3 and 4 were significantly (p<0.05) increased compared with those on day 1. The congestion scores significantly (p<0.05) decreased from day 2 to day 7 in both groups compared with those on day 1. However, the difference in the serial change in the congestion scores did not reach statistical significance.
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
| 2015 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
J Cardiol. 2018 Mar 19. pii: S0914-5087(18)30052-2. doi: 10.1016/j.jjcc.2018.02.006.
Management information
Registered date
| 2016 | Year | 02 | Month | 19 | Day |
Last modified on
| 2018 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024120
