UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012317 |
|---|---|
| Receipt number | R000014403 |
| Scientific Title | Comparison of Tolvaptan and Carperitide in acute decompensated heart failure |
| Date of disclosure of the study information | 2013/11/16 |
| Last modified on | 2013/11/16 17:05:26 |
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Basic information
Public title
Comparison of Tolvaptan and Carperitide in acute decompensated heart failure
Acronym
Comparison of Tolvaptan and Carperitide in acute decompensated heart failure
Scientific Title
Comparison of Tolvaptan and Carperitide in acute decompensated heart failure
Scientific Title:Acronym
Comparison of Tolvaptan and Carperitide in acute decompensated heart failure
Region
| Japan |
Condition
Condition
Acute decompensated heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of Tolvaptan and Carperitide in acute decompensated heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Length of hospitalization, Cost of hospitalization, One-year prognosis, Time to MACE, readmission for worsening of heart failure and death from any cause)
Number of hospitalizations
Key secondary outcomes
Changes in renal function, serum sodium and plasma BNP level
Improvement of the signs of congestion assessed by physical examination, chest X-ray and echocardiography
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
switch from Carperitide to Tolvaptan within 48 hours after admission
Interventions/Control_2
continue Carperitide
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
Acute decompensated heart failure patients initially treated with low-dose Carperitide who meet all of following criteria
1) Heart failure patients diagnosed by Framingham criteria
2) Patients with refractory fluid retention 48hrs after admission in spite of loop-diuretic therapy(equivalent to >20mg frosemide dose)
3) In-hospital patients at entry
4) 20 years of age and older patients at entry
5) Patients with written informed consent
6) Paients irrespective of sex
Key exclusion criteria
1)Patients who already have tolvaptan at entry
2) Hypernatremia(serum Na>145mEq/L)
3) Insensitivity to thurst or difficulty in water intake
4) Anuria
5) Pregnant or possibly pregnant
6) History of hypersensitivity to Tolvaptan
7) Any conditions inappropriate to this trial deemed by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Watarai |
Organization
Anjo Kosei Hospital
Division name
Department of Cardiology
Zip code
Address
28 Higashihirokute, Anjo-cho, Anjo city, Aichi Pref. JAPAN
TEL
0566-75-2111
watarai@kosei.anjo.aichi.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Miura |
Organization
Anjo Kosei Hospital
Division name
Department of Cardiology
Zip code
Address
28 Higashihirokute, Anjo-cho, Anjo city, Aichi Pref. JAPAN
TEL
0566-75-2111
Homepage URL
amiura@kosei.anjo.aichi.jp
Sponsor or person
Institute
Anjo Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
安城更生病院(愛知県)
Anjo Kosei Hospital(Aichi Pref.)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 16 | 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
| 2013 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 16 | Day |
Last modified on
| 2013 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014403
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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