A study to develop an ultrasound-based method for estimating heart relaxation and filling pressure in Japanese patients

Building the diagnostic algorithm to estimate left ventricular diastolic function and filling pressure by echocardiography in Japan - LVFP-Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000062036

Enrollment

1200

Registered

2026-06-23

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older. 2. Patients undergoing clinically indicated right heart catheterization (or left heart catheterization) and transthoracic echocardiography within 6 hours for evaluation of cardiovascular disease. Examination timing will not be adjusted for research purposes. Any treatment between the examinations, including diuretics, intravenous fluids, or oxygen, will be recorded. 3. Patients with atrial fibrillation are eligible. 4. Written informed consent is obtained from the participant.

Exclusion criteria

Exclusion criteria: 1. Severe cardiac disease requiring mechanical circulatory support or catecholamine administration. 2. Previous heart transplantation. 3. Within 1 month after cardiovascular surgery. 4. Poor echocardiographic image quality or inability to obtain required images. 5. Maintenance dialysis. 6. Severe regurgitant valvular heart disease.

Design outcomes

Primary

Measure	Time frame
At enrollment, using echocardiography and cardiac catheterization performed within 6 hours, the diagnostic performance of a Japanese echocardiography-based algorithm for identifying elevated left ventricular filling pressure will be evaluated. Elevated filling pressure is defined by invasive measurements as resting mean pulmonary capillary wedge pressure (PCWP) >15 mmHg or left ventricular pre-A pressure >15 mmHg. Performance will be assessed using the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value, negative predictive value, and calibration when appropriate.	—

Measure

Time frame

At enrollment, using echocardiography and cardiac catheterization performed within 6 hours, the diagnostic performance of a Japanese echocardiography-based algorithm for identifying elevated left ventricular filling pressure will be evaluated. Elevated filling pressure is defined by invasive measurements as resting mean pulmonary capillary wedge pressure (PCWP) >15 mmHg or left ventricular pre-A pressure >15 mmHg. Performance will be assessed using the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value, negative predictive value, and calibration when appropriate.

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Secondary

Measure	Time frame
1. Associations between echocardiographic parameters and categories of invasively measured left ventricular filling pressure: normal LVFP, 8-12 mmHg; mildly elevated LVFP, >12 and <=18 mmHg; and highly elevated LVFP, >18 mmHg, based on PCWP or left ventricular pre-A pressure. 2. Diagnostic accuracy of diastolic function grading according to the 2025 American Society of Echocardiography guideline. 3. One-year clinical outcomes after enrollment: all-cause death (cardiac or non-cardiac), rehospitalization for heart failure, and incident or recurrent atrial fibrillation among patients in sinus rhythm at enrollment.	—

Measure

Time frame

1. Associations between echocardiographic parameters and categories of invasively measured left ventricular filling pressure: normal LVFP, 8-12 mmHg; mildly elevated LVFP, >12 and <=18 mmHg; and highly elevated LVFP, >18 mmHg, based on PCWP or left ventricular pre-A pressure. 2. Diagnostic accuracy of diastolic function grading according to the 2025 American Society of Echocardiography guideline. 3. One-year clinical outcomes after enrollment: all-cause death (cardiac or non-cardiac), rehospitalization for heart failure, and incident or recurrent atrial fibrillation among patients in sinus rhythm at enrollment.

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Countries

Japan

Contacts

Public ContactKatsuji Inoue

Ehime University Graduate School of Medicine Department of Regional Emergency Medicine

inoue.katsuji.my@ehime-u.ac.jp0894-24-5127

Outcome results