Chronic Heart Failure Analysis and Registry in the Tohoku... | NCT00418041

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

NCT00418041

Sponsor

Hiroaki Shimokawa, MD, PhD

Status

Unknown status

Last Update Posted

May 12, 2015Estimated

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Heart Failure
Coronary Disease
Heart Valve Diseases
Cardiomyopathies
Left Ventricular Hypertrophy

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Mar 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jan 3, 2007

First Submission Date that Met QC Criteria

Jan 3, 2007

First Posted Date

Jan 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2015

Last Update Posted Date

May 12, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hiroaki Shimokawa, MD, PhD, Department of Cardiovascular Medicine, Tohoku UniversitySponsor-Investigator

Lead Sponsor

Hiroaki Shimokawa, MD, PhDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients in teaching hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroaki Shimokawa, MD, PhD	Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine		Sendai		980-8574	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41069488	Derived	Ito T, Nochioka K, Noda T, Shiroto T, Yamanaka S, Yamamoto N, Sato H, Chiba T, Nakano M, Inoue T, Susukita K, Takahama H, Takahashi J, Miyata S, Shimokawa H, Yasuda S. New-onset anemia and its association with ventricular arrhythmias and sudden cardiac death in patients with heart failure with preserved ejection fraction. Int J Cardiol Heart Vasc. 2025 Sep 25;61:101812. doi: 10.1016/j.ijcha.2025.101812. eCollection 2025 Dec.
40879292

ID	Term
D006333	Heart Failure
D003327	Coronary Disease
D006349	Heart Valve Diseases
D009202	Cardiomyopathies
D017379	Hypertrophy, Left Ventricular

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia
D014652	Vascular Diseases