UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007551 |
|---|---|
| Receipt number | 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 15:37:36 |
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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
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
ichibun@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007436
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
