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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014441
Receipt No. R000016573
Scientific Title The dosage, timing and duration of tolvaptan administration in Patients Hospitalized for Acute Decompensated Heart Failure
Date of disclosure of the study information 2014/07/01
Last modified on 2014/07/01

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Basic information
Public title The dosage, timing and duration of tolvaptan administration in Patients
Hospitalized for Acute Decompensated Heart Failure
Acronym The dosage, timing and duration of tolvaptan administration
Scientific Title The dosage, timing and duration of tolvaptan administration in Patients
Hospitalized for Acute Decompensated Heart Failure
Scientific Title:Acronym The dosage, timing and duration of tolvaptan administration
Region
Japan

Condition
Condition Heart Failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to determine the relationship between the dosage, timing, duration of tolvaptan administration and clinical outcome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Improvement of heart failure, duration of hospitalization, death
Key secondary outcomes Change of urine volume, vital signs, electrolytes, renal function, costs of diuretics

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The early group receives tolvaptan (5-7 days) within 2 days of hospital admission and the late group receives tolvaptan(5-7 days) from day 5 or 6 day of hospitalization
Interventions/Control_2 In case of re-admission within 6 months, the patient will be treated with continuing use of tolvaptan. we compatere first hospitalisation with second hospitalisation
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients hospitalized with heart failure
Key exclusion criteria Contraindication of usage of tolvaptan
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobukiyo Tanaka
Organization Ichinomiya Nishi Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address Ichinomiya, Japan
TEL 0586-48-0077
Email nobukiyo282000@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobukiyo Tanaka
Organization Ichinomiya Nishi Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address Ichinomiya, Japan
TEL 0586-48-0077
Homepage URL
Email nobukiyo282000@yahoo.co.jp

Sponsor
Institute Ichinomiya Nishi Hospital
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 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

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 Open public recruiting
Date of protocol fixation
2014 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 07 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
2014 Year 07 Month 01 Day
Last modified on
2014 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016573

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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