Clinical trial NCT00418041: Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study)
Official title: Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2 Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Coronary Disease
Heart Valve Diseases
Cardiomyopathies
Left Ventricular Hypertrophy
Lead sponsor: Tohoku University
Sponsor class: OTHER
First posted: 2007-01-04
Enrollment: 10000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in teaching hospitals

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:

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 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.

Primary outcomes:
measure: All-cause death
timeFrame: At the time of registration and at least once a year thereafter
measure: Non-fatal acute myocardial infarction
timeFrame: At the time of registration and at least once a year thereafter
measure: Non-fatal stroke
timeFrame: At the time of registration and at least once a year thereafter
measure: Heart failure requiring admission
timeFrame: At the time of registration and at least once a year thereafter
Secondary outcomes:
Other outcomes:
Locations:
city: Sendai-city
country: Japan
facility: Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Study officials:
affiliation: Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
name: Hiroaki Shimokawa, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.