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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010872
Receipt No. R000012555
Scientific Title Effectiveness and safety of continuous administration of tolvaptan in the treatment of refractory congestive heart failure in a multicenter cohort study
Date of disclosure of the study information 2013/06/12
Last modified on 2013/06/04

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Basic information
Public title Effectiveness and safety of continuous administration of tolvaptan in the treatment of refractory congestive heart failure in a multicenter cohort study
Acronym Continuous administration of tolvaptan in the treatment of refractory congestive heart failure
Scientific Title Effectiveness and safety of continuous administration of tolvaptan in the treatment of refractory congestive heart failure in a multicenter cohort study
Scientific Title:Acronym Continuous administration of tolvaptan in the treatment of refractory congestive heart failure
Region
Japan

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

Objectives
Narrative objectives1 To clarify the effectiveness and saty of long term administration of tolvaptan in the patients who were prescribed tolvaptan for reduction of excessive body fluid in hospital and were prescribed tolvaptan as the medicarion at discharge
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Functional heart failure status
Key secondary outcomes 1) change in body weight
2) change in congestion (edema, rales)
3) Blood test (CBC, serum Na, serum K, Uric acid, BUN, Cre)
4) serum osmolality
5) plasma BNP concentration
6) urinary osmolality
7) change in UCG findings
8) change in ECG findings

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients with heart failure
They receive tolvaptan when they dischage.
They take loop diuretics, thiazide, and/or aldosterone antagonist
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Masuyama
Organization Hyogo College of Medicine
Division name Cardiovascular Medicine
Zip code
Address 1-1 Mukogawa Nishinomiya
TEL 81-798-45-6553
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Hirotani
Organization Hyogo College of Medicine
Division name Cardiovascular Medicine
Zip code
Address 1-1 Mukogawa Nishinomiya
TEL 81-798-45-6553
Homepage URL
Email hirotani@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine, Division of Cardiovascular Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine, Division of Cardiovascular Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 兵庫医科大学(兵庫県)、関西労災病院 循環器内科(兵庫県)、おおくまセントラル病院(兵庫県)、兵庫県立尼崎病院(兵庫県)、川崎病院(兵庫県)、明和病院(兵庫県)


Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 12 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 Preinitiation
Date of protocol fixation
2013 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cardiac performance status

Management information
Registered date
2013 Year 06 Month 04 Day
Last modified on
2013 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012555

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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