UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012716 |
|---|---|
| Receipt number | R000014852 |
| Scientific Title | Clinical efficacy and safety of the ealry intervention with Tolvaptan(V2 receptorinhibiter)in hospitalized patients with acute exacerbation of chronic heart failur:A randomized open-labeled parallel controlled study |
| Date of disclosure of the study information | 2013/12/27 |
| Last modified on | 2020/01/08 13:18:28 |
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Basic information
Public title
Clinical efficacy and safety of the ealry intervention with Tolvaptan(V2 receptorinhibiter)in hospitalized patients with acute exacerbation of chronic heart failur:A randomized open-labeled parallel controlled study
Acronym
Clinical efficacy and safety of the ealry intervention with Tolvaptan(V2 receptorinhibiter)in hospitalized patients with acute exacerbation of chronic heart failur:A randomized open-labeled parallel controlled study
Scientific Title
Clinical efficacy and safety of the ealry intervention with Tolvaptan(V2 receptorinhibiter)in hospitalized patients with acute exacerbation of chronic heart failur:A randomized open-labeled parallel controlled study
Scientific Title:Acronym
Clinical efficacy and safety of the ealry intervention with Tolvaptan(V2 receptorinhibiter)in hospitalized patients with acute exacerbation of chronic heart failur:A randomized open-labeled parallel controlled study
Region
| Japan |
Condition
Condition
Acute exacerbation of chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of the early treatment with tolvaptan(V2receptor inhibiter)in hospitalized patients with acute exacerbation of chronic heart failure by comparing with the dose escalation treatment of loor diuretics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Body weight change from baseline to day7
Key secondary outcomes
1 Average urine volumes of 3 days from day1 to day3
2 Differences of chest radiographic findings between baseline and day3,day7.
3 Changes of congestive heart failure symptoms from baseline : Dyspnea,JVD,Hepatic edema,Lower limb edema.
4 Changes of serum and urinary electrolyte concentration.; Na,K,Cl,Ca,Mg.
5 Changes of vital sign ; Blood pressure,Heart rate
6 Endocrine factors:Plasma renin activity,plasma aldosterone,urinary adorenalin,urinary noadorenalin,urinary dopamine
7 Serum creatinine
8 Loop Diuretics dose at discharge
9 Total amount of loop diuretic dose in the hospital
10 Occurrence of cardiovascular events and rehospitalization due to exacerbation of chronic heart failur in 6months after discharge
11 Adverse events in the hospital and 6months after discharge
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 not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of 7.5mg to 15mg/day tolvaptan is started at the next day of admission and kept for 7 days, as an additional treatment to conventional therapy.The administration doses of any othre oral diuretics at admission are kept to discharge.
Interventions/Control_2
Doses of oral loop diuretics are increased in need from the next day of admission for 7 days.The administration doses of any other oral diuretics are kept from admission to discharge.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Patients with acute exacerbation of chronic heart failure.
2 Patients aged between 20 and 85 at giving the informed consent.
3 Patients who received loop diuretics (20mg/day or more of Frosemide,30mg/day or more of Azosemide,4mg/day or more of Torasemide.)
4 Patients with more than one of following congestive symptoms; dyspnea,pulmonary congestion,juglar venous distention,lower limb edema.
5 Patients who can receive drugs orally.
6 Patients with less than 3mg/dL of serum creatinine.
7 Patients who gave the infoemed consent to participate in the study of their own free will.
Key exclusion criteria
1 Patients with a history of hypersensitivity for an ingredient of tolvaptan or analogues such as Mozavaptan.
2 Patients with lowering consciousness.
3 Patients who need treatment with respirator.
4 Patients who receive artificial dialysis.
5 Patients with anuria.
6 Patients with severe liver disfunction.
7 Patients who cannot feel thirst or are difficult to intake the fluid.
8 Patients with hypernatremia.
9 Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant.
10 Patients otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Sueyoshi |
Organization
UJI-TOKUSHUKAI MEDICAL CENTER
Division name
Cardiovascular Medicine
Zip code
Address
86 Kasugamori Ogura-cho Uji-city Kyoto, 611-0042 Japan
TEL
0774-20-1111
rinri@ujitoku.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Sueyoshi |
Organization
UJI-TOKUSHUKAI MEDICAL CENTER
Division name
Cardiovascular Medicine
Zip code
Address
86 Kasugamori Ogura-cho Uji-city Kyoto, 611-0042 Japan
TEL
0774-20-1111
Homepage URL
rinri@ujitoku.or.jp
Sponsor or person
Institute
UJI-TOKUSHUKAI MEDICAL CENTER Cardiovascular Medicine
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
Haibara General Hospital Cardiovascular Medicine
Name of secondary funder(s)
None
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 | 12 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 07 | 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 | 12 | Month | 27 | Day |
Last modified on
| 2020 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014852
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