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Heart FailureNCT00418041

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

An observational study of Heart Failure and Coronary Disease, run by Hiroaki Shimokawa, MD, PhD at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
How many people
10,000 participants
Where
1 siteJapan
Study dates
Oct 2006to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients in teaching hospitals

Who may be able to join

  • 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.

Who cannot join

  • Patients with age<20 years old.
  • Patients who refused to participate.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

    Sendai, 980-8574

Other trials in Japan

About this study

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.
Read the 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.
Medical subject headings
Heart Failure, Coronary Disease, Heart Valve Diseases, Cardiomyopathies, Hypertrophy, Left Ventricular

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause death

    Measured: At the time of registration and at least once a year thereafter

  2. Non-fatal acute myocardial infarction

    Measured: At the time of registration and at least once a year thereafter

  3. Non-fatal stroke

    Measured: At the time of registration and at least once a year thereafter

  4. Heart failure requiring admission

    Measured: At the time of registration and at least once a year thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2007 (estimated)
  2. Study startOct 2006
  3. Primary completionMar 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00418041
Sponsor's protocol ID
2006-115
Status last verified
May 2015
First submitted
3 Jan 2007
Last updated
12 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41069488

  • 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.

    PubMed 40879292

  • 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.

    PubMed 39150084

  • 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.

    PubMed 32113664

  • 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.

    PubMed 32107021

  • 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.

    PubMed 30866657

  • 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.

    PubMed 29540427

  • 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.

    PubMed 26356834

  • 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.

    PubMed 24088306

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Coronary Disease, run by Hiroaki Shimokawa, MD, PhD at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause death (time frame: At the time of registration and at least once a year thereafter). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00418041, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.

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