UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term Effect of Tolvaptan Administration for Outcome and Neurohormonal Factors in Patients with Heart Failure
Title of the study (Brief title)	Clinical Effect of Long-term Tolvaptan Administration
Region	Japan

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

Objectives
Narrative objectives1	To examine the clinical effect of long-term Tolvaptan administration in patients with heart failure with fluid retention. Especially, to examine the effects of neurohormonal factors and renal function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes in neurohormonal factors (catecholamine, renin activity, aldosterone, copeptin)
Key secondary outcomes	The finding of fluid retention, the changes in serum sodium, BUN, Cr, urinary L-FABP, dosage of diuretics, blood pressure, heart rate and 6-month prognosis (readmission and death)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Assigned following 2 groups, when heart failure treatment is hemodynamically stable. TLV group: Add on tolvaptan (1.875mg/day to 15mg/day) with conventional diuretics for 6 months.
Interventions/Control_2	Conventinal diuretics group: Treat with conventional diuretics except tolvaptan for 6 months.
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	Heart failure in-hospital patients with fluid retention Required continuous diuretics treatment
Key exclusion criteria	Patients with a history of hypersensitivity for tolvaptan or an analogue. Anuresis or hypernatremia. Patients who have difficulty with fluid intake or can not feel dipsesis. Pregnant woman or possibility of the pregnancy. Patients whom tolvaptan is already given at registration. Patients whom study responsibility physician judged inappropriate.
Target sample size	100

Research contact person
Name of lead principal investigator	Kiyoshi Iida
Organization	Nihon University Surugadai Hospital
Division name	Department of Cardiology
Address	1-8-13 Kanda-Surugadai, Chiyoda, Tokyo
TEL	03-3293-1711
Email	kiida2830@jcom.home.ne.jp

Public contact
Name of contact person	Kiyoshi Iida
Organization	Nihon University Surugadai Hospital
Division name	Department of Cardiology
Address	1-8-13 Kanda-Surugadai, Chiyoda, Tokyo
TEL	03-3293-1711
Homepage URL
Email	kiida2830@jcom.home.ne.jp

Sponsor
Institute	Nihon University Surugadai Hospital
Institute
Department

Funding Source
Organization	none
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	駿河台日本大学病院（東京都）、日本大学板橋病院（東京都）、聖路加国際病院（東京都）、三井記念病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 09 Day
Anticipated trial start date	2014 Year 03 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 04 Month 25 Day
Last modified on	2017 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015336