UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011213
Receipt No. 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

* 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
Email

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
Email

Sponsor
Institute Department of cardiovascular medicine
Osaka city university graduate school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.