About EBLM

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  • About EBLM

History

October 2004
The “Division of Evidence-Based Laboratory Medicine” was established as an endowed course in the field of Clinical Laboratory Medicine and Immunology, supported by Sysmex Corporation.
(Division Head: Professor Shunichi Kumagai)
October 2012
The division was transferred to the Department of Internal Medicine and renamed the “Department of Evidence-Based Laboratory Medicine.”
(Division Head: Professor Ken-ichi Hirata)
October 2024
20th Anniversary of the establishment of the endowed course.
Professor Masakazu Shinohara was appointed as the new Division Head.

Mission・Vision

We aim to scientifically validate the clinical value of laboratory testing and contribute to the improvement of healthcare quality.

Based on clinical epidemiological evidence, we aim to validate the usefulness of diagnostic methods and establish effective applications of laboratory testing. Through this approach, we ensure the quality of diagnosis and treatment, contribute to the advancement of diagnostic medicine and healthcare, and ultimately enhance the health and well-being of the population.

01 Validation of Clinical Testing Methods and Public Outreach
02 Discovery of Novel Clinical Testing Seeds for Various Diseases and Conditions
03 Fostering Talent in Basic Research and Clinical Laboratory Science

Research Themes

1. Development of Novel Clinical Testing Methods

In recent years, the importance of predictive medicine—a preventive approach that intervenes before the onset of symptoms by assessing an individual’s risk for disease—has been increasingly recognized. To realize predictive medicine, it is essential to develop testing methods and biomarkers that can quickly and accurately identify and stratify disease risks, taking into account genetic background, environmental factors, and lifestyle habits. Our division focuses on the development of novel biomarkers and testing methods related to atherosclerosis and cardiovascular diseases, utilizing clinical specimens collected from patients at Kobe University Hospital and affiliated institutions. Notable achievements from our collaborative research with Sysmex Corporation include: A method to evaluate the functionality of high-density lipoprotein (HDL), A screening technique for cardiac amyloidosis.
Traditionally, HDL cholesterol (HDL-C) has been quantitatively assessed as a negative risk factor for coronary artery disease. However, recent studies suggest that "the higher, the better" is no longer a universally valid indicator. In response, we developed a novel measurement system—Cholesterol Uptake Capacity (CUC)—which enables simple, rapid, and highly reproducible evaluation of HDL’s ability to uptake cholesterol. We have demonstrated that CUC may be a more effective tool for cardiovascular risk assessment than HDL-C. CUC is now fully automated and undergoing clinical validation both in Japan and internationally.
In addition, wild-type transthyretin cardiac amyloidosis (ATTRwt-CM) has recently gained attention due to findings that it is present in approximately 10% of patients with common cardiovascular conditions, such as aortic stenosis and heart failure with preserved ejection fraction (HFpEF). However, definitive diagnosis of ATTRwt-CM currently requires invasive and costly procedures such as tissue biopsy or 99mTc-PYP scintigraphy, and there are no simple screening methods available.
To address this, we are working toward the development of a non-invasive blood-based screening test, aiming to identify specific biomarkers and establish a diagnostic algorithm for ATTRwt-CM.

The Pathogenic Process Triggered by Unstable Transthyretin (TTR)
The Pathogenic Process Triggered by Unstable Transthyretin (TTR)

Detection of TTR tetramer by ELISA

Schematic Diagram of the TTR Instability Evaluation System Developed in This Study

Schematic Diagram of the TTR Instability Evaluation System Developed in This Study

Source: Sci Rep. 2024;14(1):20508.

2. Elucidating the Pathophysiology of Heart Disease through Basic Research

Basic research plays a vital role in the advancement of medicine and is essential for nurturing future researchers. It provides an indispensable opportunity to learn how to construct scientific hypotheses and verify them through experimentation.
Our division focuses primarily on basic research related to heart failure. The heart is often described as an “omnivorous organ,” as it utilizes a variety of energy substrates—including fatty acids, glucose, amino acids, and ketone bodies—to produce ATP. When myocardial tissue is damaged due to conditions such as ischemic heart disease or valvular disease, the pattern of energy substrate utilization changes prior to structural remodeling. This phenomenon is known as metabolic remodeling.
We utilize advanced omics approaches, such as metabolomics analysis, and conduct studies using various biological materials including human specimens, animal models of heart failure, and cultured cells. Our goal is to characterize the metabolic properties of individual cell types that constitute the heart.
In recent years, we have explored novel pathophysiological mechanisms that were previously overlooked in myocardium-centered research. These include:

  • Dysregulation of branched-chain amino acid (BCAA) metabolism in diabetic cardiomyopathy
  • The role of the de novo fatty acid synthesis pathway in cardiac fibroblasts

These findings have contributed valuable insights to the academic field.
Moving forward, we aim not only to deepen our understanding of heart failure pathophysiology but also to establish new therapeutic strategies by targeting metabolic pathways. We are committed to promoting translational research that bridges basic science and clinical practice.

Angiotensin-II/Cardiac Fibrosis Induced by Angiotensin II or Phenylephrine Is Suppressed by Silencing of the Acly Gene (Masson's Trichrome Staining)
Cardiac Fibrosis Induced by Angiotensin II or Phenylephrine Is Suppressed by Silencing of the Acly Gene (Masson's Trichrome Staining)

Activated cardiac fibroblast

Pathogenic Mechanism of Cardiac Fibrosis Centered on ACLY, Elucidated by Our Laboratory

Pathogenic Mechanism of Cardiac Fibrosis Centered on ACLY, Elucidated by Our Laboratory

Source: Hypertension. 2025;82(6):1116–1128.

3. Community-Based Epidemiological Research

Japan is experiencing a rapid progression of super-aging, making it essential to conduct high-precision, community-based epidemiological studies in order to accurately assess public health challenges and formulate effective healthcare policies and prevention strategies. Heart failure, in particular, is a chronic condition whose prevalence is markedly increasing with aging. It results from the heart’s inability to adequately supply blood to the body’s organs, leading to symptoms such as shortness of breath, edema, and fatigue, and often requiring repeated hospitalizations. The number of heart failure patients in Japan is estimated at around 1.2 million and is expected to increase further, posing a serious public health issue referred to as the “heart failure pandemic.” As the risk of onset rises with age, this condition greatly impacts not only life expectancy and quality of life (QOL) but also healthcare economics, making it a critical issue for building a sustainable healthcare system.
However, forecasting the future number of heart failure patients in Japan is fraught with uncertainty, largely due to a lack of reliable epidemiological data that reflect the actual conditions at the regional level. To address this gap, we are participating in a community-based epidemiological study led by Hyogo Prefectural Awaji Medical Center: Kobe University Heart Failure Registry in Awaji Medical Center (KUNIUMI Registry). This project aims to investigate the real-world situation of heart failure patients in Awaji Island. Based on analyses from this registry, it was estimated that approximately 160,000 new cases of acute heart failure occurred in 2015, and this number is projected to increase to around 250,000 by 2040. Notably, the proportion of patients aged 85 and older is expected to rise significantly, accounting for over 60% of total cases by 2040.
These findings strongly emphasize the need for preventive strategies and early intervention for heart failure, and provide valuable evidence to support the development of elderly care systems and integrated community-based care. In fact, the results of this study were included in the 2025 Guidelines for the Diagnosis and Treatment of Heart Failure by the Japanese Circulation Society and are widely recognized as foundational data for Japan’s national heart failure policy. We will continue to advance regionally grounded epidemiological research to deepen our understanding of heart failure and enhance countermeasures, thereby contributing to sustainable healthcare and community development in Japan’s super-aged society.

Estimated number of HFp/rEF in Japan

Estimated number of HFpEF and HFrEF (thousand)

HFpEF HFrEF % of HFpEF Total population in Japan(million)
2015 82.8 76.4 52.0 125.9
2020 98.8 86.4 53.3 125.3
2025 112.2 94.7 54.2 122.9
2030 125.1 101.8 55.1 119.2
2035 136.7 106.4 56.3 114.8
2040 142.3 108.9 56.7 111.0
2045 139.6 107.1 56.6 106.6
2050 138.9 106.5 56.6 101.9
2055 144.1 107.4 57.3 97.3

Trends in HFpEF and HFrEF* Patients**
Fujimoto, Toh, Takegami, et al. Circulation Journal, 2021.
*HFpEF (Heart Failure with Preserved Ejection Fraction): A type of heart failure in which systolic function is preserved.
**HFrEF (Heart Failure with Reduced Ejection Fraction): A type of heart failure characterized by reduced systolic function.

Source: Circulation Journal. 2021;85(10):1860–1868.

* This research was included in the 2025 revised edition of the “Guidelines for the Diagnosis and Treatment of Heart Failure” published by the Japanese Circulation Society.