UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011213 |
|---|---|
| Receipt number | R000013142 |
| Scientific Title | Effects of low dose tolvaptan in old myocardial infarction patients with congestive heart failure |
| Date of disclosure of the study information | 2013/07/18 |
| Last modified on | 2015/05/13 10:59:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of low dose tolvaptan in old myocardial infarction patients with congestive heart failure
Acronym
Effects of low dose tolvaptan in old myocardial infarction patients with congestive heart failure
Scientific Title
Effects of low dose tolvaptan in old myocardial infarction patients with congestive heart failure
Scientific Title:Acronym
Effects of low dose tolvaptan in old myocardial infarction patients with congestive heart failure
Region
| Japan |
Condition
Condition
Old myocardial infarction patients with congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of long administration of low dose tolvaptan for suppressing myocardial remodeling in old myocardial infarction patients with congestive heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Left ventricular ejection fraction(LVEF)
Key secondary outcomes
NYHA class, body weight, congestive findings(leg edema, jugular vein dilatation, pulmonary congestion ), serum sodium, serum potassium, diastolic function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of tolvaptan 3.75mg/day
Interventions/Control_2
non-administration of tolvaptan
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Old myocardial infarction patients with congestive
heart failure
2) EF < 50%
3) Physical findings of congestion
4) No significant stenosis in coronary arteries
Key exclusion criteria
1) Patients with severe hypotention or cardioganic shock
2) Patients with cardiac assist device
3) Patients on hemodialysis
4) Patients with systolic blood pressure < 90mmHg
5) Patients with serum Na > 147 mEq/L or serum K > 5.5
mEq/L or T- bilirubin > 3.0 mg/dL
6) Patients considered not eligible for the study by the
attending doctor due to other reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Yoshiyama |
Organization
Osaka city university graduate school of medicine
Division name
Department of cardiovascular medicine
Zip code
Address
1-4-3, Asahimachi Abeno-ku, Osaka
TEL
06-6645-3801
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihisa Hanatani |
Organization
Osaka city university graduate school of medicine
Division name
Department of cardiovascular medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of cardiovascular medicine
Osaka city university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of cardiovascular medicine
Osaka city university graduate school of medicine
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
| 2013 | Year | 07 | Month | 18 | 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 | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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
| 2013 | Year | 07 | Month | 17 | Day |
Last modified on
| 2015 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013142
