UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000062036
Receipt number	R000070985
Scientific Title	Building the diagnostic algorithm to estimate left ventricular diastolic function and filling pressure by echocardiography in Japan
Date of disclosure of the study information	2026/06/23
Last modified on	2026/06/23 20:47:46

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Basic information

Public title

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

Acronym

LVFP-Japan

Scientific Title

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

Scientific Title:Acronym

LVFP-Japan

Region

Japan

Condition

Heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

This multicenter prospective observational study aims to clarify the associations between echocardiographic parameters and invasively measured left ventricular filling pressure obtained by cardiac catheterization, and to develop echocardiography-based diagnostic algorithms for left ventricular diastolic function and filling pressure that are appropriate for Japanese patients. Separate prediction algorithms will be developed for patients in sinus rhythm and those with atrial fibrillation because of differences in hemodynamics and available echocardiographic parameters.

Basic objectives2

Others

Basic objectives -Others

Evaluation of diagnostic performance and development of a diagnostic algorithm

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

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.

Key secondary outcomes

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.

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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.

Target sample size

1200

Research contact person

Name of lead principal investigator

1st name Katsuji

Middle name

Last name Inoue

Organization

Ehime University Graduate School of Medicine

Division name

Department of Regional Emergency Medicine

Zip code

796-8502

Address

1-638 Ohira, Yawatahama, Ehime, Japan

TEL

0894-24-5127

Email

inoue.katsuji.my@ehime-u.ac.jp

Public contact

Name of contact person

1st name Katsuji

Middle name

Last name Inoue

Organization

Ehime University Graduate School of Medicine

Division name

Department of Regional Emergency Medicine

Zip code

796-8502

Address

1-638 Ohira, Yawatahama, Ehime, Japan

TEL

0894-24-5127

Homepage URL

Email

inoue.katsuji.my@ehime-u.ac.jp

Sponsor or person

Institute

Ehime University Graduate School of Medicine

Institute

Department

Personal name

Funding Source

Organization

Ehime University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Department of Cardiology, Nagoya City University Graduate School of Medical Sciences

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Clinical Research Ethics Review Committee, Ehime University Hospital

Address

454 Shitsukawa, Toon, Ehime 791-0295, Japan

Tel

089-960-5914

Email

rinri@m.ehime-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

愛媛大学医学部附属病院（愛媛県）
名古屋市立大学大学院医学研究科循環器内科学（愛知県）
群馬大学大学院医学研究科循環器内科学（群馬県）
高知大学老年病・循環器内科学（高知県）
名古屋市立大学医学部附属東部医療センター循環器内科（愛知県）
関西医科大学附属病院第二内科・循環器内科（大阪府）
喜多医師会病院循環器内科（愛媛県）
広島大学病院循環器内科（広島県）
三重大学医学部附属病院循環器・腎臓内科学（三重県）
松山赤十字病院循環器内科（愛媛県）
筑波大学附属病院循環器内科（茨城県）
藤田医科大学病院循環器内科（愛知県）
新潟大学医歯学総合病院循環器内科学（新潟県）
岡山大学病院循環器内科（岡山県）
愛知医科大学病院循環器内科（愛知県）
自治医科大学内科学講座循環器内科（栃木県）
島根大学医学部附属病院循環器内科（島根県）
東邦大学医療センター大橋病院循環器内科（東京都）
熊本大学病院中央検査部兼循環器内科（熊本県）
天理よろづ相談所病院循環器内科（奈良県）
産業医科大学病院循環器内科・腎臓内科（福岡県）

Other administrative information

Date of disclosure of the study information

2026 Year 06 Month 23 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

There is currently no plan to share individual participant data.

IPD sharing Plan description

Individual participant data collected in this study will not be shared at the individual participant level without approval by an ethics review committee and permission from the head of the research institution. Study results will be presented at scientific meetings and published in journals only as aggregate data without identifying individual participants.

Progress

Recruitment status

Preinitiation

Date of protocol fixation

2026 Year 02 Month 25 Day

Date of IRB

2026 Year 06 Month 08 Day

Anticipated trial start date

2026 Year 09 Month 01 Day

Last follow-up date

2029 Year 12 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

This is a multicenter prospective observational cohort study. Eligible participants are patients aged 18 years or older who undergo right heart catheterization or left heart catheterization and transthoracic echocardiography within 6 hours for evaluation of cardiac disease. Clinical characteristics, laboratory data, natriuretic peptide levels, echocardiographic parameters, cardiac catheterization parameters, anonymized echocardiographic DICOM data, and 1-year follow-up outcomes will be collected as part of routine clinical care. No additional intervention will be performed for research purposes. The primary outcome is elevated left ventricular filling pressure based on invasive measurements, defined as resting PCWP >15 mmHg or LV pre-A pressure >15 mmHg. Diagnostic algorithms for estimating left ventricular filling pressure by echocardiography in Japan will be developed separately for patients in sinus rhythm and those with atrial fibrillation.

Management information

Registered date

2026 Year 06 Month 23 Day

Last modified on

2026 Year 06 Month 23 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070985