UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Oral medication using Tolvaptan for ADL of patients with acute congestive heart failure
Title of the study (Brief title)	Oral medication using Tolvaptan for ADL of patients with acute congestive heart failure
Region	Japan

Condition
Condition	acute heart failure
Classification by specialty	Medicine in general Cardiology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether oral medication using Tolvaptan for hospitalized patients with acute heart failure prevents impairment in ADL compared with conventional intravenous infusion treatment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	activity of daily living (ADL), quality of life (QOL)
Key secondary outcomes	Duration of hospitalization, place of discharge, cost

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	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	conventional intravenous treatment (without Tolvaptan)
Interventions/Control_2	oral treatment including Tolvaptan (avoiding continuous intravenous therapy)
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	agreement by patients beyond 20 years old diagnosed with acute congestive heart failure
Key exclusion criteria	acute myocardial infarction severe respiratory failure (PaO2<60Torr, and/or SPO2<90% on oxygen administration) shock vital (sBP<90mmHg) serum sodium >146
Target sample size	60

Research contact person
Name of lead principal investigator	Masashi Kasao
Organization	Tokyo Metropolitan Police Hospital
Division name	Department of Cardiology
Address	4-22-1, Nakano, Nakano, Tokyo, 164-8541
TEL	+81-3-5343-5611
Email	mu3948@hotmail.com

Public contact
Name of contact person	Kazutaka Ueda
Organization	Tokyo Metropolitan Police Hospital
Division name	Department of Cardiology
Address	4-22-1, Nakano, Nakano, Tokyo, 164-8541
TEL	+81-3-5343-5611
Homepage URL
Email	ueda-cib@umin.ac.jp

Sponsor
Institute	Tokyo Metropolitan Police Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Police Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2014 Year 02 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 20 Day
Anticipated trial start date	2014 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 06 Day
Last modified on	2017 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015276