UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009136 |
|---|---|
| Receipt number | R000010504 |
| Scientific Title | Short term clinical efficacy and safety of Tolvaptan additional treatment compared with escalation treatment of conventional diuretics in HF patients with volume overload despite treatments with the conventional diuretics |
| Date of disclosure of the study information | 2012/10/31 |
| Last modified on | 2016/04/24 15:53:37 |
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Basic information
Public title
Short term clinical efficacy and safety of Tolvaptan additional treatment compared with escalation treatment of conventional diuretics in HF patients with volume overload despite treatments with the conventional diuretics
Acronym
Short term clinical efficacy and safety of Tolvaptan additional treatment compared with dose up conventional diuretics treatment in HF patients with volume overload despite the treatment with the conventional diuretics
Scientific Title
Short term clinical efficacy and safety of Tolvaptan additional treatment compared with escalation treatment of conventional diuretics in HF patients with volume overload despite treatments with the conventional diuretics
Scientific Title:Acronym
Short term clinical efficacy and safety of Tolvaptan additional treatment compared with dose up conventional diuretics treatment in HF patients with volume overload despite the treatment with the conventional diuretics
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of additional tolvaptan treatment by comparing with dose up conventional diuretics treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Body weight change from baseline to day7 and day12
Body weight change from day12 to day14
Key secondary outcomes
Average urine volume from day1 to day7
Congestive symptoms
Serum electrolyte concentration
Serum creatinine concentration
Neurohumoral factors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administered group of loop diuretics furosemide 40mg oral or equivalent
Interventions/Control_2
Administered group of Torvaptan
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
Patients who were diagnosed of heart failure.
Patients with either congestive symptoms of dyspnea, pulmonary, congestion, pulmonary rale, third heart sound, juglar venous distention, lower limb edema.
Patients who received loop diuretics at a daily dosage equivalent to 40 mg or more of furosemide.
Male or female patients between the ages of 20 and 85, inclusive (at time of informed consent)
Patients capable of giving informed consent to participate in the study of their own free will.
Key exclusion criteria
Patients with a history of hypersensitivity for an ingredient of tolvaptan or an analogue (Mozavaptan)
Patients with anuria
Patients who cannot feel thirst or are difficult to intake the fluid.
Patients with hypernatremia.
Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant.
Patients who are diagnosed following diseases
A) Serious coronary artery disease, cerebrovascular disease
B) Hyperkalemia
C) Serious Renal failure
D) Diabetes mellitus with poorly controlled blood glucose
E) Serious hepatic disorder
F) Urinary excretion disorder in order to the stenosis of the urinary tract
G) Valvular disease that in order to valvular stenosis is severe
H) Malignant tumor
Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimura Takeshi |
Organization
Kyoto University Hospital
Division name
Cardiovascular internal medicine
Zip code
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL
075-751-4254
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Imai Masao |
Organization
Kyoto University Hospital
Division name
Cardiovascular internal medicine
Zip code
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL
075-751-4255
Homepage URL
m_imai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University 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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 31 | 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
| 2012 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 18 | Day |
Last modified on
| 2016 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010504
