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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hiroaki Shimokawa, MD, PhD, Tohoku University
ClinicalTrials.gov Identifier:
NCT00418041
First received: January 3, 2007
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

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.

Condition
Heart Failure
Coronary Disease
Heart Valve Diseases
Cardiomyopathies
Left Ventricular Hypertrophy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study)

Resource links provided by NLM:


Further study details as provided by Tohoku University:

Primary Outcome Measures:
  • All-cause death [ Time Frame: At the time of registration and at least once a year thereafter ] [ Designated as safety issue: Yes ]
  • Non-fatal acute myocardial infarction [ Time Frame: At the time of registration and at least once a year thereafter ] [ Designated as safety issue: Yes ]
  • Non-fatal stroke [ Time Frame: At the time of registration and at least once a year thereafter ] [ Designated as safety issue: Yes ]
  • Heart failure requiring admission [ Time Frame: At the time of registration and at least once a year thereafter ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10000
Study Start Date: October 2006
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients in teaching hospitals

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418041

Locations
Japan
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Sendai-city, Japan, 980-8574
Sponsors and Collaborators
Hiroaki Shimokawa, MD, PhD
Investigators
Study Chair: Hiroaki Shimokawa, MD, PhD Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
  More Information

Additional Information:
No publications provided by Tohoku University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hiroaki Shimokawa, MD, PhD, Department of Cardiovascular Medicine, Tohoku University
ClinicalTrials.gov Identifier: NCT00418041     History of Changes
Other Study ID Numbers: 2006-115
Study First Received: January 3, 2007
Last Updated: May 11, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Cardiomyopathies
Coronary Artery Disease
Coronary Disease
Heart Failure
Heart Valve Diseases
Hypertrophy
Hypertrophy, Left Ventricular
Arterial Occlusive Diseases
Arteriosclerosis
Cardiomegaly
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathological Conditions, Anatomical
Vascular Diseases

ClinicalTrials.gov processed this record on July 27, 2015