UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of tolvaptan in heart failure patients with loop diuretic resistance.
Title of the study (Brief title)	The effect of tolvaptan in heart failure patients with loop diuretic resistance.
Region	Japan

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

Objectives
Narrative objectives1	To assess the effect of tolvaptan in heart failure patients with loop diuretic resistance and the predictor of tolvaptan responder.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in body weight
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	administration of tolvaptan
Interventions/Control_2
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 heart failure patients with informed consent, and whose urine production is less than 200ml over 2h after intravenous bolus of furosemide.
Key exclusion criteria	1. patients with cardiogenic shock or needs catecholamine or mechanical circulation support 2. intubation 3. obvious bleeding or active gastrointestinal ulceration 4. hemodialysis 5. hyperkalemia (6.0mEq/L) 6. hypernatremia (150mEq/L) 7. hypotension (systolic blood pressure <=85mmHg) or symptomatic hypotension 8. patients who cannot declare thirst or cannot drink water 9. hypersensitivity for Tolvaptan or Mozavaptan 10. expectant mother 11. inappropriate patients judged by the physician in charge
Target sample size	50

Research contact person
Name of lead principal investigator	Nobuhisa Hagiwara
Organization	Tokyo Women's Medical University
Division name	Department of cardiology
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	mokayama@hij.twmu.ac.jp

Public contact
Name of contact person	Kentaro Jujo
Organization	Tokyo Women's Medical University
Division name	Department of cardiology
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	juken1123@mac.com

Sponsor
Institute	Tokyo Women's Medical University, Department of Cardiology
Institute
Department

Funding Source
Organization	none
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	2015 Year 02 Month 27 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 01 Month 24 Day
Anticipated trial start date	2014 Year 02 Month 27 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	2015 Year 02 Month 27 Day
Last modified on	2016 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018947