UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000562
Receipt number 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 11:27:19

* 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

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 or person

Institute

Tohoku Heart Failure Association
The CHART-2 Study Group

Institute

Department

Personal name



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

Value
https://center6.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