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

NCT ID: NCT00418041

Last Updated: 2015-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure Coronary Disease Heart Valve Diseases Cardiomyopathies Left Ventricular Hypertrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hiroaki Shimokawa, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Hiroaki Shimokawa, MD, PhD

Department of Cardiovascular Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hiroaki Shimokawa, MD, PhD

Role: STUDY_CHAIR

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

Locations

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Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

Sendai, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 41069488 (View on PubMed)

Ito T, Noda T, Nochioka K, Shiroto T, Yamamoto N, Sato H, Hayashi H, Chiba T, Nakano M, Takahama H, Takahashi J, Miyata S, Shimokawa H, Yasuda S. Association of a mild or an important decline in left ventricular ejection fraction with ventricular tachyarrhythmias, sudden cardiac death, and all-cause death in heart failure with preserved ejection fraction: a report from the CHART-2 Study. Europace. 2025 Sep 1;27(9):euaf184. doi: 10.1093/europace/euaf184.

Reference Type DERIVED
PMID: 40879292 (View on PubMed)

Ito T, Noda T, Nochioka K, Shiroto T, Yamamoto N, Sato H, Chiba T, Hasebe Y, Nakano M, Takahama H, Takahashi J, Miyata S, Shimokawa H, Yasuda S. Clinical impact of atrial fibrillation progression in patients with heart failure with preserved ejection fraction: A report from the CHART-2 Study. Europace. 2024 Aug 30;26(9):euae218. doi: 10.1093/europace/euae218.

Reference Type DERIVED
PMID: 39150084 (View on PubMed)

Aoyanagi H, Nochioka K, Sakata Y, Miura M, Shiroto T, Abe R, Kasahara S, Sato M, Fujihashi T, Yamanaka S, Hayashi H, Sugimura K, Takahashi J, Miyata S, Shimokawa H; CHART-2 Investigators. Temporal changes in left ventricular ejection fraction and their prognostic impacts in patients with Stage B heart failure. Int J Cardiol. 2020 May 1;306:123-132. doi: 10.1016/j.ijcard.2020.02.040. Epub 2020 Feb 15.

Reference Type DERIVED
PMID: 32113664 (View on PubMed)

Takada T, Sakata Y, Nochioka K, Miura M, Abe R, Kasahara S, Sato M, Aoyanagi H, Fujihashi T, Yamanaka S, Suzuki K, Shiroto T, Sugimura K, Takahashi J, Miyata S, Shimokawa H; CHART-2 Investigators. Risk of de-novo heart failure and competing risk in asymptomatic patients with structural heart diseases. Int J Cardiol. 2020 May 15;307:87-93. doi: 10.1016/j.ijcard.2020.02.015. Epub 2020 Feb 6.

Reference Type DERIVED
PMID: 32107021 (View on PubMed)

Suzuki K, Oikawa T, Nochioka K, Miura M, Kasahara S, Sato M, Aoyanagi H, Shiroto T, Takahashi J, Miyata S, Sakata Y, Shimokawa H. Elevated Serum Non-HDL (High-Density Lipoprotein) Cholesterol and Triglyceride Levels as Residual Risks for Myocardial Infarction Recurrence Under Statin Treatment. Arterioscler Thromb Vasc Biol. 2019 May;39(5):934-944. doi: 10.1161/ATVBAHA.119.312336.

Reference Type DERIVED
PMID: 30866657 (View on PubMed)

Oikawa T, Sakata Y, Nochioka K, Miura M, Tsuji K, Onose T, Abe R, Kasahara S, Sato M, Shiroto T, Takahashi J, Miyata S, Shimokawa H; CHART-2 invesigators. Prognostic Impact of Statin Intensity in Heart Failure Patients With Ischemic Heart Disease: A Report From the CHART-2 (Chronic Heart Failure Registry and Analysis in the Tohoku District 2) Study. J Am Heart Assoc. 2018 Mar 14;7(6):e007524. doi: 10.1161/JAHA.117.007524.

Reference Type DERIVED
PMID: 29540427 (View on PubMed)

Ushigome R, Sakata Y, Nochioka K, Miyata S, Miura M, Tadaki S, Yamauchi T, Sato K, Onose T, Tsuji K, Abe R, Oikawa T, Kasahara S, Takahashi J, Shimokawa H; CHART-2 Investigators. Temporal trends in clinical characteristics, management and prognosis of patients with symptomatic heart failure in Japan -- report from the CHART Studies. Circ J. 2015;79(11):2396-407. doi: 10.1253/circj.CJ-15-0514. Epub 2015 Sep 10.

Reference Type DERIVED
PMID: 26356834 (View on PubMed)

Miura M, Sakata Y, Miyata S, Nochioka K, Takada T, Tadaki S, Takahashi J, Shiba N, Shimokawa H; CHART-2 Investigators. Usefulness of combined risk stratification with heart rate and systolic blood pressure in the management of chronic heart failure. A report from the CHART-2 study. Circ J. 2013;77(12):2954-62. doi: 10.1253/circj.cj-13-0725. Epub 2013 Oct 1.

Reference Type DERIVED
PMID: 24088306 (View on PubMed)

Other Identifiers

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2006-115

Identifier Type: -

Identifier Source: org_study_id

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