Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study)

Heart Failure Clinical Trial

Official title:

Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00418041
• Other study ID #: 2006-115
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Heart Valve Diseases
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

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

External Links

•   Click here for more information about this study: CHART-2 Study