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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00418041
Other study ID # 2006-115
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 3, 2007
Last updated May 11, 2015
Start date October 2006
Est. completion date December 2019

Study information

Verified date May 2015
Source Tohoku University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study) is a large, prospective, hospital-based cohort study to investigate the following:

- Characteristics of patients with chronic heart failure and prognostic risks of these patients.

- Characteristics of patients with high risk for heart failure and critical factors which predict the development of symptomatic heart failure in these patients.

- The incidence and prognostic impact of metabolic syndrome in patients with chronic heart failure.

- The association between metabolic syndrome and the development of symptomatic heart failure.


Description:

The CHART-2 Study is a multicenter prospective observational cohort study identifying the characteristics, mortality and prognostic risks of patients with overt HF and patients without HF but who are at high risk for disease progression of cardiovascular diseases (CVD).

The purposes of the study are as follows:

1. to elucidate characteristics of patients with overt HF and the associated prognostic risks

2. to elucidate characteristics of patients at risk for HF and the factors associated with CVD progression

3. to elucidate factors associated with the development of AHFS

4. to elucidate prevalence and prognostic impact of metabolic syndrome (MetS) in patients with overt HF

5. to elucidate the association between MetS and the development of AHFS

6. to elucidate the prevalence and prognostic impact of malignancy in patients with CVD

7. to elucidate the prevalence of patients needing home nursing care and the characteristics of bedridden patients with CVD.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10000
Est. completion date December 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Structural heart disease but without signs or symptoms of heart failure.

- Structural heart disease with prior or current symptoms of heart failure.

- Refractory heart failure requiring specialized interventions.

- Patients with prior cardiovascular surgery or percutaneous coronary intervention and those who need such interventions.

Exclusion Criteria:

- Patients with age<20 years old.

- Patients who refused to participate.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Japan Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine Sendai-city

Sponsors (1)

Lead Sponsor Collaborator
Hiroaki Shimokawa, MD, PhD

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause death At the time of registration and at least once a year thereafter Yes
Primary Non-fatal acute myocardial infarction At the time of registration and at least once a year thereafter Yes
Primary Non-fatal stroke At the time of registration and at least once a year thereafter Yes
Primary Heart failure requiring admission At the time of registration and at least once a year thereafter Yes
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