UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure.
Acronym	Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure.
Scientific Title	Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure.
Scientific Title:Acronym	Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure.
Region	Japan

Condition
Condition	Acute decompensated heart failure
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Changes in circulating plasma volume during Tolvaptan combined use in Acute decompensated heart failure in the elderly.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in circulating plasma volume by IVC.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are 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	Conventional therapy group
Interventions/Control_2	Tolvaptan add-on therapy group
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	76 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Acute decompensated heart failure patients diagnosed by Framingham criteria. 2.Patients who are able to take oral medications 3.age 76 over 4.Partients hospitalized for over time visits
Key exclusion criteria	1.Under 75 2.Hypersensitivity for Tolvaptan or Mozavaptan. 3.Anuria 4.Insensitivity to thurst of difficulty in water in take. 5.Patients who already have tolvaptan at entry. 6.Severe coronary arterydisease and cerebrovascular disease. 7.Severe renal failure 8.Hypernatremia(serum Na>146mEq/L)and(serum Na<125mEq/L). 9.Hyperkalemia(serum K>5.5mEq/L)and(serum K<3.0mEq/L). 10.Chronic hepatitis Liver dysfunction(pharmacological etc.). 11.Hepatic encephalopathy. 12.Any conditions inappropriate to this trial deemed by the investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norihiro Ashihara
Organization	Shinshu University Hospital
Division name	Second Department of Internalmedicine
Zip code
Address	3-1-1,Asahi,Matsumoto.Nagano.Japan
TEL	0263-37-2634
Email	asha_trial@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Yasushi Takizawa
Organization	Iiyama redcross hospital
Division name	Division of pharmacy
Zip code
Address	Iiyama226-1,Iiyama.Nagano.Japan
TEL	0269-62-4195
Homepage URL
Email	asha_trial@yahoo.co.jp

Sponsor
Institute	Iiyama redcross hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

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

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 03 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	2017 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date	2017 Year 02 Month 28 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	2017 Year 07 Month 02 Day
Last modified on	2018 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032102

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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