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

May 11, 2015 updated by: Hiroaki Shimokawa, MD, PhD

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.

Study Overview

Status

Unknown

Conditions

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:

  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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Sendai-city, Japan, 980-8574
        • Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients in teaching hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause death
Time Frame: At the time of registration and at least once a year thereafter
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
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
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
At the time of registration and at least once a year thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hiroaki Shimokawa, MD, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (ESTIMATE)

January 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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