JRCT ID: jRCT1030250395
Registered date:29/09/2025
Development of a Novel Echocardiographic Evaluation Method Quantifying the Variability of Intraventricular Blood Flow Velocity Vecto
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Heart failure with reduced ejection fraction (HFrEF) |
| Date of first enrollment | 29/09/2025 |
| Target sample size | 50 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Primary Endpoint Age-group differences in energy loss (EL) derived from Vector Flow Mapping (VFM) analysis. The study evaluates changes in intracardiac hemodynamics associated with age and developmental stage by comparing EL values across different age groups. In addition to the conventional comparison between individuals aged (65 and 65 years, stratified analyses involving three or more age groups will be conducted as needed. |
|---|---|
| Secondary Outcome | Secondary Endpoint Comparison of energy loss (EL) values between healthy adults and patients with heart failure with reduced ejection fraction (HFrEF). EL values obtained through Vector Flow Mapping (VFM) analysis will be compared between the following two groups: Healthy group (LVEF 50%) HFrEF group (patients with a history of myocardial infarction and reduced LVEF) This comparison aims to elucidate the characteristics of intracardiac energy loss associated with impaired cardiac function. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | |
| Include criteria | Healthy Group (Control Group) No restriction on age or sex Underwent transthoracic echocardiography including Vector Flow Mapping (VFM) Left ventricular ejection fraction (LVEF) 50% Reduced Cardiac Function Group (HFrEF Group) History of myocardial infarction Underwent transthoracic echocardiography including Vector Flow Mapping (VFM) |
| Exclude criteria | Individuals receiving outpatient treatment for arrhythmia (including those with implanted pacemakers; however, those with only premature contractions are not excluded) Individuals with moderate or severe valvular disease (aortic or mitral valve) Individuals with a history of heart failure who have been previously hospitalized (applies only to the healthy group) Individuals undergoing maintenance dialysis Any other individuals deemed inappropriate for participation in this study by the principal investigator or attending physician Even in the case of pediatric subjects (e.g. preschool or school-age children), the above exclusion criteria shall generally apply. However, the presence or absence of relevant diagnoses or treatment history, as well as medical eligibility, shall be judged clinically according to age and developmental stage. |
Related Information
| Primary Sponsor | Ootani Naoyuki |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Naoyuki Ootani |
| Address | 145-1Moritomo, Nikko City, Tochigi Prefecture, Japan Tochigi Japan 321-1298 |
| Telephone | +81-288-23-7000 |
| naoyuki@dokkyomed.ac.jp | |
| Affiliation | Dokkyo Medical University Nikko Medical Center |
| Scientific contact | |
| Name | Naoyuki Ootani |
| Address | 145-1Moritomo, Nikko City, Tochigi Prefecture, Japan Tochigi Japan 321-1298 |
| Telephone | +81-288-23-7000 |
| naoyuki@dokkyomed.ac.jp | |
| Affiliation | Dokkyo Medical University Nikko Medical Center |