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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007551
Receipt No. R000007436
Scientific Title Study of influential factor to responsiveness of Tolvaptan in patients with volume overload heart failure -Multicenter prospective observational study-
Date of disclosure of the study information 2012/04/01
Last modified on 2012/03/22

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Basic information
Public title Study of influential factor to responsiveness of Tolvaptan in patients with volume overload heart failure -Multicenter prospective observational study-
Acronym Tolvaptan Registry
Scientific Title Study of influential factor to responsiveness of Tolvaptan in patients with volume overload heart failure -Multicenter prospective observational study-
Scientific Title:Acronym Tolvaptan Registry
Region
Japan

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

Objectives
Narrative objectives1 Investigate of factor affecting the responsiveness of Tolvaptan on patients with congestive heart failure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Change of body weight
Key secondary outcomes 1.Change of congestive state
2.Change of urine volume, osmolarity
3.Change of plasma BNP level
4.One-Year Outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Hospitalized patients at the start of administration of Tolvaptan tablets
2.Patients who takes existing diuretic
Key exclusion criteria 1.Patients with hypernatremia
2.Inability of the patient to sense or appropriately respond to thirst
3.Anuric patients
4.Pregnant, possibly pregnant, or nursing women
5.Patients with a history of hypersensitivity to ingredients of Tolvaptan tablets
6.Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ito
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Cardiovascular Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazufumi Nakamura
Organization Okayama University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7351
Homepage URL
Email ichibun@cc.okayama-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2012 Year 04 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
2011 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information age, gender, height, weight, underlying disease, type of heart failure, presence and type of arrhythmias, presence of pacemaker, presence of AICD, previous illness and complications, NYHA classification, EF, congestive findings(dyspnea, orthopnea, leg edema, etc), type and dose of diuretic, drugs for heart failure, other drugs, urine volume, urine osmolarity, physical examination (chest x-ray, echocardiography, etc.), hematology (hemoglobin, hematocrit, etc.), biochemical test (total protein, albumin, urea nitrogen, creatinine, uric acid, cystatin, sodium, potassium, etc), urine sodium excretion, plasma BNP concentration, plasma Renin activity, plasma AVP concentration, serum osmolarity, outcomes (cardiovascular events, hospitalization for heart failure, all-cause mortality)

Management information
Registered date
2012 Year 03 Month 22 Day
Last modified on
2012 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007436

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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