Observational multicenter registry to DEvelop updaTed Echocardiographic Cut-off and algorithm for early deTection of Pulmonary Hypertension

UMIN ID: UMIN000055583

Registered date:22/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who underwent right heart catheterization
• Date of first enrollment: 2024/09/22
• Target sample size: 3000
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The positivity rate of echocardiographic indicators in cases with mean pulmonary artery pressure greater than 20 mmHg as measured by right heart catheterization. The positivity rate of echocardiographic indicators in cases with mean pulmonary artery pressure greater than 20 mmHg, pulmonary artery wedge pressure less than or equal to 15 mmHg, and pulmonary vascular resistance greater than 2 WU as measured by right heart catheterization.
• Secondary Outcome: Correlation between right heart catheterization indicators and echocardiographic indicators. Occurrence of cardiovascular events during the follow-up period. Occurrence of all-cause mortality during the follow-up period. Interventions for pulmonary hypertension during the follow-up period. Physical findings: Changes in WHO/NYHA functional class, 6-minute walk distance, and cardiopulmonary exercise test results from baseline to the end of the observation period.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Patients who received treatment interventions that could affect hemodynamics between the echocardiography and right heart catheterization (such as dialysis, medication administration, etc.) 2. Patients for whom echocardiography could not be performed within 48 hours before or after the right heart catheterization due to scheduling constraints or the clinical system 3. Patients who requested to withdraw from the study or revoked their consent 4. Patients deemed unsuitable for the study by the principal investigator for any other reason

Related Information

• Primary Sponsor: University of Tsukuba
• Source(s) of Monetary Support: Japan Society for the Promotion of Science (JSPS) Grants-in-Aid for Scientific Research (KAKENHI),The Japanese Society of Echocardiography