UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012439 |
|---|---|
| Receipt number | R000013411 |
| Scientific Title | Acute Effects of Tolvaptan on Acute Exacerbation of Chronic Heart Failure |
| Date of disclosure of the study information | 2013/11/29 |
| Last modified on | 2014/11/30 10:16:44 |
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Basic information
Public title
Acute Effects of Tolvaptan on Acute Exacerbation of Chronic Heart Failure
Acronym
ACT-HF
Scientific Title
Acute Effects of Tolvaptan on Acute Exacerbation of Chronic Heart Failure
Scientific Title:Acronym
ACT-HF
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study is to evaluate the efficacy of oral tolvaptan administration to compare with standard therapy with carperitide and furosemide injection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Average urinary volume in a day and body weight change, at fifth or the last day of the treatment
Key secondary outcomes
1) NT-proBNP; before and fifth or the last day of the treatment
2) serum Na, K, creatinie; before and fifth or the last day of the treatment
3) IVC diameter by echocardiography; before and fifth or the last day of the treatment
4) urinary osmorarity; before and fifth or the last day of the treatment
5) oxidative stress marker change; serum and urine
6) event frequency during 90 days after hospital discharge
7) cost of heart failure treatment during hospital admission; cost of treatment or admission fee
Base
Study type
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 not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with oral topvaptan
Interventions/Control_2
treatment with carperitide and fulosemide injection
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
1) NYHA class II or III heart failure patient with volume overload
2) patient who can take medicine orally
3) patient who's systolic blood pressure is 90 mmHg or more at hospital admission
4) patient who is at least 20 years old when he or she agreed to this study
5) patient who agreed within 24 hours after hospital admission
Key exclusion criteria
1) heart failure patient by coronary artery disease
2) patient who has allergic past history to tolvaptan or relative chemicals
3) patient of no urine production
4) patient who do not feel thirsty or have difficulty to take water orally
5) patient who is hypernatremia
6) patient who is pregnant or might be pregnant
7) patient who is very low blood pressure or cardiogenic shock state
8) patient who suffers right ventricular myocardial
infarction
9) patient who have dehydration
10) patient who is assessed to be inappropriate for the study by study investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Maemura |
Organization
Nagasaki University
Division name
Cardiovasucular Medicine
Zip code
Address
1-7-1 Sakamoto Nagasaki, Nagasaki, JAPAN
TEL
+81-95-819-7288
maemura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Koide |
Organization
Nagasaki University Hosital
Division name
Cardiovascular Medicien
Zip code
Address
1-7-1 Sakamoto Nagasaki, Nagasaki, JAPAN
TEL
+81-95-819-7288
Homepage URL
ykoide1@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences
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
長崎大学病院(長崎県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 29 | 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
| 2013 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 29 | Day |
Last modified on
| 2014 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013411
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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