UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Tolvaptan on hemodynamic of congestive heart failure.
Acronym	Effect of Tolvaptan on hemodynamic of congestive heart failure.
Scientific Title	Effect of Tolvaptan on hemodynamic of congestive heart failure.
Scientific Title:Acronym	Effect of Tolvaptan on hemodynamic of congestive heart failure.
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study si to evaluate the efficacy of Tolvaptan on hemodynamic of congestive heart failure patients. The hemodynamic is evaluated by Swan-Gantz catheter.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	hemodynamic
Key secondary outcomes

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 group Tolvaptan 7.5mg/day and Fulosemide 10mg/day are administered for 7days. If not effective, Tolvaptan is administered up to 15mg/day.
Interventions/Control_2	Control group Fulosemide in administered for 7days.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients who diagnosed Congestive heart failure 2. NYHA class III or IV 3. Patients who are admitted to our hospital.
Key exclusion criteria	1. Hypernatremia (serum sodium >= 146mEq/L) 2. Hyponatremia (serum sodium < 125mEq/L) 3. Hyperkalemia (serum potassium >= 5.1mEq/L) 4. Anuric patients 5. Renal insufficiency (serum creatinine > 4.0mEq/L 6. Systolic blood pressure < 90mmHg 7. Severe coronary artery disease or cerebrovascular disease 8. Hypertrophic obstructive cardiomyopathy or severe valvular heart disease 9. Patients who cannot declare thirst or cannot drink water 10. Expectant mother 11. Patients who implanted pace maker, ICD, CRT-D or mechanical valves 12. Intubation 13. Hypersensitivity for Tolvaptan or Mozavaptan 14. Inappropriate patients judged by the physician in charge
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshihide Fujimoto
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code
Address	1-8-1 Inohana Chuo-ku Chiba city Chiba 260-8677 Japan
TEL	043-226-2340
Email	LapisLazurite@hotmail.com

Public contact
Name of contact person	1st name Middle name Last name Keishi Ishikawa
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code
Address	1-8-1 Inohana Chuo-ku Chiba city Chiba 260-8677 Japan
TEL	043-226-2340
Homepage URL
Email	LapisLazurite@hotmail.com

Sponsor
Institute	Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	G23045
Org. issuing International ID_1	Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 31 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	2011 Year 09 Month 30 Day
Date of IRB	2014 Year 03 Month 31 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 30 Day
Last modified on	2021 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014227