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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000562
Receipt No. R000000683
Scientific Title Chronic Heart Failure Analysis and Registry in the Tohoku District 2
Date of disclosure of the study information 2006/12/26
Last modified on 2011/12/26

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Basic information
Public title Chronic Heart Failure Analysis and Registry in the Tohoku District 2
Acronym CHART-2 study
Scientific Title Chronic Heart Failure Analysis and Registry in the Tohoku District 2
Scientific Title:Acronym CHART-2 study
Region
Japan

Condition
Condition Chronic heart failure
Patients with high risk for heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To investigate characteristics of patients with chronic heart failure and to seek for prognostic risks of these patients.
2) To investigate characteristics of patients with high risk for heart failure and to seek for risks to predict the development of symptomatic heart failure in these patients.
Basic objectives2 Others
Basic objectives -Others 1) To investigate the incidence and prognostic impact of metabolic syndrome in patients with chronic heart failure.
2) To investigate the association between metabolic syndrome and the development of symptomatic heart failure.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) all-cause death
2) cardiovascular death
3) development of congestive heart failure
Key secondary outcomes 1) death due to heart failure
2) sudden death
3) acute myocardial infarction
4) stroke
5) hospital admission from any cardiovascular reasons
6) fatal arrhythmia or appropriate ICD discharge
7) new-onset diabetes
8) development of renal failure
9) new-onset atrial fibrillation
10) a need to modify treatment procedures for heart failure
11) left ventricular ejection fraction
12) BNP
13) nutritional status
14) metabolic syndrome

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Structural heart disease but without signs or symptoms of heart failure.
2) Structural heart disease with prior or current symptoms of heart failure.
3) Refractory heart failure requiring specialized interventions.
4) Patients with prior cardiovascular surgery or percutaneous coronary intervention and those who need such interventions.
Key exclusion criteria Mone
Target sample size 10000

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-city
TEL 022-717-7153
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Shiba
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai-city
TEL 022-717-7153
Homepage URL http://tohoku.cardiovascular-medicine.jp
Email nshiba@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku Heart Failure Association
The CHART-2 Study Group
Institute
Department

Funding Source
Organization None
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
2006 Year 12 Month 26 Day

Related information
URL releasing protocol http://tohoku.cardiovascular-medicine.jp
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 No longer recruiting
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
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1) Hospital-based prospective cohort study.
2) Patients who met the inclusion criteria will be registered consecutively in 18 hospitals.
3) The association between baseline characteristics of patients and the mortality/morbidity of those will be evaluated.

Management information
Registered date
2006 Year 12 Month 26 Day
Last modified on
2011 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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