UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022260 |
|---|---|
| Receipt number | R000025647 |
| Scientific Title | Prospective multicenter study on severe heart failure due to chronic ischemic heart disease |
| Date of disclosure of the study information | 2016/05/16 |
| Last modified on | 2023/11/14 11:31:37 |
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Basic information
Public title
Prospective multicenter study on severe heart failure due to chronic ischemic heart disease
Acronym
Prospective multicenter study on severe heart failure due to chronic ischemic heart disease
Scientific Title
Prospective multicenter study on severe heart failure due to chronic ischemic heart disease
Scientific Title:Acronym
Prospective multicenter study on severe heart failure due to chronic ischemic heart disease
Region
| Japan |
Condition
Condition
Severe heart failure due to chronic ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate background factors and progress of the prognosis with the heavy heart failure patients who were considered no therapeutics without heart transplantation in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the survival rate for the life prognosis
Key secondary outcomes
1) The absence of hospitalization rate due to any serious cardiovascular events.
2) The ratio of 5% or more improvement about LVEF at 6 months after registration.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･chronic ischemic heart disease.
･LVEF <35%
･NYHA class 3 or 4.
･Drug therapy with maximal oral medication including digitalis, diuretic, angiotensin-converting enzyme inhibitors, angiotensin 2 receptor blockers, beta-blockers, and diuretics.
･Patients with worsening heart failure after standard treatments (CABG, mitral valvuloplasty, surgical ventricular restoration, CRT, and PCI).
Key exclusion criteria
N/A
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichi |
| Middle name | |
| Last name | Momomura |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Cardiovascular Medicine
Zip code
330-8503
Address
1-847 Amanum-cho, Omiya-ku, Saitama-City, Saitama Japan
TEL
048-647-2111
momoshin@omiya.jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Tamada |
Organization
Terumo Corporation
Division name
Clinical Development Department
Zip code
163-1450
Address
Tokyo Opera City Tower 49F, 3-20-2, Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6742-8500
Homepage URL
Rinshokenkyu_HS@terumo.co.jp
Sponsor or person
Institute
Terumo Corporation
Institute
Department
Personal name
Funding Source
Organization
Terumo Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
-
Address
1-847 Amanum-cho, Omiya-ku, Saitama-City, Saitama Japan
Tel
048-647-2111
-
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
| 2016 | Year | 05 | Month | 16 | 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
103
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because the research report is currently being prepared
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational, prospective study
Management information
Registered date
| 2016 | Year | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025647
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
