UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018014 |
|---|---|
| Receipt number | R000020874 |
| Scientific Title | Chronic Heart failure Analysis and Registry in the Tohoku district 2 ; Improved Long-term Prognosis of Patients with Dilated Cardiomyopathy with implementation of Evidenced-based Medications -A Report from the CHART Studies- |
| Date of disclosure of the study information | 2015/06/22 |
| Last modified on | 2015/06/22 15:44:53 |
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Basic information
Public title
Chronic Heart failure Analysis and Registry in the Tohoku district 2 ; Improved Long-term Prognosis of Patients with Dilated Cardiomyopathy with implementation of Evidenced-based Medications -A Report from the CHART Studies-
Acronym
CHART-2 Study
Scientific Title
Chronic Heart failure Analysis and Registry in the Tohoku district 2 ; Improved Long-term Prognosis of Patients with Dilated Cardiomyopathy with implementation of Evidenced-based Medications -A Report from the CHART Studies-
Scientific Title:Acronym
CHART-2 Study
Region
| Japan |
Condition
Condition
Dilated Cardiomyopathy
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Idiopathic dilated cardiomyopathy (DCM) is a disorder of the heart muscle in which the heart chambers are progressively enlarged or dilated. In the Chronic Heart Failure Analysis and Registry in the Tohoku District (CHART) Studies, we reported that the use of renin angiotensin system inhibitors and beta-blockers for chronic heart failure patients was significantly increased, whereas that of loop diuretics and digitalis had decreased in the past years. Recent trends in the clinical characteristics, management and prognosis of DCM patients in Japan, however, remain to be examined.
Basic objectives2
Others
Basic objectives -Others
In the present study, we thus examined the recent trends in baseline charac- teristics, treatment and long-term prognosis of DCM patients, by comparing the CHF database between the CHART-1 and CHART-2 Studies.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) All-cause death
2) Cardiovascular death
3) Hospitalization for worsening heart failure
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Additional Blood Sampling (5mL)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
DCM defined in the guidelines of the Japanese Circulation Society
Key exclusion criteria
None
Target sample size
1014
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Shimokawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
+81-22-717-7153
shimo@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Sakata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
+81-22-717-7153
Homepage URL
sakatayk@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine and Department of Evidence-Based Cardiovascular Medicine, Tohoku University Graduate School of Medicine and Tohoku heart failure association
Institute
Department
Personal name
Funding Source
Organization
Department of Evidence-Based Cardiovascular Medicine, Tohoku University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2006 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | 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
| 2015 | Year | 06 | Month | 22 | Day |
Last modified on
| 2015 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020874
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
