UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006258 |
|---|---|
| Receipt number | R000007409 |
| Scientific Title | Randomized controlled trial of tolvaptan and carperitide to fluid retention in patients with congestive heart failure |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2014/03/02 14:19:40 |
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Basic information
Public title
Randomized controlled trial of tolvaptan and carperitide to fluid retention in patients with congestive heart failure
Acronym
Randomized trial of tolvaptan and carperitide on heart failure patients
Scientific Title
Randomized controlled trial of tolvaptan and carperitide to fluid retention in patients with congestive heart failure
Scientific Title:Acronym
Randomized trial of tolvaptan and carperitide on heart failure patients
Region
| Japan |
Condition
Condition
Acute congestive heart failure (including acute exacerbation of chronic heart failure) patietnts
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the acute effectiveness and long-term usefulness of tolvaptan on congestive heart failure patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Daily urine volume of first, second, third, fourth, seventh, and day 14th after admission (or dicharge)
Key secondary outcomes
Body weight of subjective symptoms
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tolvaptan group: 7.5-15mg/day oral administration
Interventions/Control_2
Carperitide group: 0.0125-0.025µg/kg/min continuous intravenous administration (-0.2µg/kg depending on the condition)
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
(1) Patients with fluid retention in congestive heart failure
(2) Patients who were hospitalized for treatment of heart failure
Key exclusion criteria
(1) Patients with circulatory assist device
(2) Acute myocardial infarction
(3) Patients with dehydration
(4) Severe hypotension or cardiogenic shock
(5) Patients with right heart ventricular infarction
(6) Patients are considered undesirable rapid decrease in blood flow circulation
(7) Patietns with hypersensitivity to study drug
(8) Anuric patients
(9) Insensitivity to the thirst or difficult for the water intake
(10) Hypernatremia (serum Na>147mEq/L)
(11) Pregnant woman, lactational woman, patients may be willing to be pregnant or are pregnant
(12) In addition, patients were judged as inadequate by physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuchika Takeishi |
Organization
Fukushima Medical University
Division name
Deaprtment of Cardiology and Hematology
Zip code
Address
1 Hikarigaoka, Fukushima, 960-1295, Japan
TEL
024-547-1190
takeishi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Suzuki |
Organization
Fukushima Medical University
Division name
Deaprtment of Cardiology and Hematology
Zip code
Address
1 Hikarigaoka, Fukushima, 960-1295, Japan
TEL
024-547-1190
Homepage URL
ssatoshi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japanese Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine
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
| 2011 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
One hundred and nine hospitalized ADHF patients were enrolled and randomly assigned to tolvaptan or carperitide treatment groups. Subjective symptoms and plasma BNP level were similarly improved by treatment in both groups. Urine volume was significantly higher in the tolvaptan group (P<0.05), but volume of water intake was also higher in the tolvaptan group (P<0.05). Blood pressure was significantly lower in the carperitide group than in the tolvaptan group after treatment (P<0.05). Less adverse events such as worsening heart failure and hypotension requiring drug discontinuation were observed in the tolvaptan group (P=0.027). The average drug cost of tolvaptan was lower than that of carperitide (P<0.001).
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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 31 | Day |
Last modified on
| 2014 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007409
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| Registered date | File name |
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| Registered date | File name |
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