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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012170
Receipt No. R000014227
Scientific Title Effect of Tolvaptan on hemodynamic of congestive heart failure.
Date of disclosure of the study information 2013/10/31
Last modified on 2018/05/04

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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 No longer recruiting
Date of protocol fixation
2011 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
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
2018 Year 05 Month 04 Day


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


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