UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009810 |
|---|---|
| Receipt number | R000011499 |
| Scientific Title | Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial. |
| Date of disclosure of the study information | 2013/01/19 |
| Last modified on | 2013/01/19 14:13:14 |
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Basic information
Public title
Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.
Acronym
Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.
Scientific Title
Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.
Scientific Title:Acronym
Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of tolvaptan for improvements in renal function and time to re-hopitalization in congestive heart failure patients with volume overload.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of change of serum creatinine
Key secondary outcomes
body weight, daily urine volume, dyspnea, congestive findings(leg edema, jugular vein dilatation, pulmonary congestion ), serum sodium, serum potassium, cystitis C, time to re-hospitalization.
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Conventional therapy only
Interventions/Control_2
Conventional therapy with 14 days administration of tolvaptan 7.5mg/day.
Interventions/Control_3
Conventional therapy with 7 days administration of tolvaptan 15mg/day.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Congestive heart failure patients to administrating loop diuretics with volume overload in hospital.
Key exclusion criteria
1) Patients who a history of hypersensitivity to tolvaptan
2) Patients with severe hypotention or cardioganic shock
3) Patients with cardiac assist device
4) Patients with dehydration
5) Patients with systolic blood pressure < 90mmHg
6) Patients with serum Na > 147 mEq/L or serum K > 5.5 mEq/L or T- bilirubin > 3.0 mg/dL
7)Patients considered not eligible for the study by the attending doctor due to other reasons
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Take |
Organization
Saiseikai Noe hospital
Division name
Department of cardiology
Zip code
Address
1-3-25, furuichi, joto-ku, osaka city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro kato |
Organization
Saiseikai Noe hospital
Division name
Department of cardiology
Zip code
Address
1-3-25, furuichi, joto-ku, osaka city
TEL
0669320401
Homepage URL
Sponsor or person
Institute
Saiseikai Noe hospital
Institute
Department
Personal name
Funding Source
Organization
Department of cardiology
Saiseikai Noe hospital
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
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
| 2013 | Year | 01 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 19 | Day |
Last modified on
| 2013 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011499
