UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of efficacy of tolvaptan for chronic congective heart failure complicated with chronic kidney disease.
Title of the study (Brief title)	TOLVAPTAN study
Region	Japan

Condition
Condition	Chronic congestive heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effects of tolvaptan for chronic heart failure with chronic kidney disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement effect of the heart failure
Key secondary outcomes	BNP, renin activity, aldosteron, catecholamine, CRE, cystatin C, urine L-FABP

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Tolvaptan
Interventions/Control_2	Furosemide
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients of congestive heart failure hospitalized with the chronic kidney disease that presented body fluid retention even if taken more than furosemide 20mg/day.
Key exclusion criteria	Patients who had acute myocardial infarction within 30 days . Patients of active myocarditis or the amyloid cardiomyopathy. Patients who are supported by circulation device. Patients who had decrease in circulation blood volume. Patients with hypertrophic cardiomyopathy (except the expansion aspect). Patients with severe valvular disease. Patients with hepatogenic comatose. Patients with insufficient treatment on diabetes mellitus. Patients whose blood pressure is less than 90mmHg. Patients that following electrolytes abnormality is accepted. Serum Na>147mEq/L, serum K>5.5mEq/L Patients who cannot take oral formulation. Patients with a pregnant woman, a nursing girl, pregnant possibility or the intention to become pregnant. Patients that are recognized as inappropriate for this study.
Target sample size	20

Research contact person
Name of lead principal investigator	Shinya Minatoguchi
Organization	Gifu University Graduate School of Medicine
Division name	Department of Cardiology
Address	1-1 Yanagido, Gifu
TEL	058-230-6523
Email	minatos@gifu-u.ac.jp

Public contact
Name of contact person	Shinya Minatoguchi
Organization	Gifu University Graduate School of Medicine
Division name	Department of Cardiology
Address	1-1 Yanagido, Gifu
TEL	058-230-6523
Homepage URL
Email	minatos@gifu-u.ac.jp

Sponsor
Institute	Department of Cardiology, Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Cardiology, Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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 07 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 06 Month 01 Day
Anticipated trial start date	2012 Year 06 Month 20 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 19 Day
Last modified on	2018 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016339