Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- All-cause death
Study Overview
Brief 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.
Detailed 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:
- to elucidate characteristics of patients with overt HF and the associated prognostic risks
- to elucidate characteristics of patients at risk for HF and the factors associated with CVD progression
- to elucidate factors associated with the development of AHFS
- to elucidate prevalence and prognostic impact of metabolic syndrome (MetS) in patients with overt HF
- to elucidate the association between MetS and the development of AHFS
- to elucidate the prevalence and prognostic impact of malignancy in patients with CVD
- to elucidate the prevalence of patients needing home nursing care and the characteristics of bedridden patients with CVD.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
All-cause death
Time Frame: At the time of registration and at least once a year thereafter
Heart failure requiring admission
Time Frame: At the time of registration and at least once a year thereafter
Non-fatal stroke
Time Frame: At the time of registration and at least once a year thereafter
Non-fatal acute myocardial infarction
Time Frame: At the time of registration and at least once a year thereafter
Secondary Outcomes
No secondary outcomes reported
Investigators
Hiroaki Shimokawa, MD, PhD
Department of Cardiovascular Medicine
Tohoku University