UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014134 |
|---|---|
| Receipt number | R000015841 |
| Scientific Title | The effect of tolvaptan on renal function during intensive treatment in patients with congestive heart failure |
| Date of disclosure of the study information | 2014/05/31 |
| Last modified on | 2014/11/04 21:20:05 |
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Basic information
Public title
The effect of tolvaptan on renal function during intensive treatment in patients with congestive heart failure
Acronym
Renoprotective effect of tolvaptan in acute phase of patients with congestive heart failure
Scientific Title
The effect of tolvaptan on renal function during intensive treatment in patients with congestive heart failure
Scientific Title:Acronym
Renoprotective effect of tolvaptan in acute phase of patients with congestive heart failure
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect on renal function, hemodynamics and neurohumoral factors in acute phase of HF patients between tolvaptan and furosemide.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
renal function
Key secondary outcomes
1. daily urine volume, fluid balance
2. plasma renin activity, plasma aldosterone concentration, catecholamines, BNP
3. systemic blood pressure
4. electrolytes
5. cardio-thoracic ratio
6. durations of NIPPV use, CCU and total hospitalization
7. in-hospital and long-term mortality
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
(Standard treatment group)
Daily 40 mg of intravenous furosemide (20 mg x 2), in addition to intravenous 0.025 gamma of carperitide and 200 mg of canrenoate potassium for 5 days. Renal functions and neurohumoral factors were evaluated on day 6 after the admission.
Interventions/Control_2
(Tolvaptan treatment group)
Daily 7.5 mg of oral Tolvaptan administration (7.5 mg x 1), in addition to intravenous 0.025 gamma of carperitide and 200 mg of canrenoate potassium for 5 days. Renal functions and neurohumoral factors were evaluated on day 6 after the admission.
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
| 30 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient urgently hospitalized due to acute heart failure syndrome, or worsened chronic heart failure, with informed consent.
Key exclusion criteria
(i) Patient with malignant neoplasm who is expected that life expectancy is within 6 months
(ii) Maintenance dialysis patient
(iii) Patient with shock or pre shock vital signs on admission
(iv) Patient younger than 30 years old
(v) Inadequate patient judged by principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Jujo |
Organization
Nishiarai Heart Center Hospital
Division name
Department of Cardiology
Zip code
Address
1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL
+81358380730
juken1123@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Jujo |
Organization
Nishiarai Heart Center Hospital
Division name
Department of Cardiology
Zip code
Address
1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL
+81358380730
Homepage URL
juken1123@hotmail.co.jp
Sponsor or person
Institute
Nishiarai Heart Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Nishiarai Heart Center Hospital
Organization
Division
Category of Funding Organization
Other
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
西新井ハートセンター病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | 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
| 2014 | Year | 05 | Month | 31 | Day |
Last modified on
| 2014 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015841
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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