UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of administration of Tolvaptan twice daily in hospitalized acute heart failure patients
Title of the study (Brief title)	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	Haruo Kamiya
Organization	Japanese Red Cross Nagoya First Hospital
Division name	Department of Cardiology
Address	3-35, Michishita-cho, Nakamura-ku, Nagoya city, Aichi, Japan
TEL	052-481-5111
Email	oguricap0909@gmail.com

Public contact
Name of contact person	Mitsutoshi Oguri
Organization	Kasugai Municipal Hospital
Division name	Department of Cardiology
Address	1-1-1 Takaki-cho, Kasugai Aichi 486-8510, Japan
TEL	0568-57-0057
Homepage URL
Email	oguricap0909@gmail.com

Sponsor
Institute	Japanese Red Cross Nagoya First Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024120