A Prospective Observational Study Evaluating Lung Drug Clearance Using Isosorbide Dinitrate as a Probe.

UMIN ID: UMIN000055919

Registered date:23/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients scheduled for both heart catheterization and endomyocardial biopsy, with planned use of isosorbide dinitrate (ISDN) During the Procedure.
• Date of first enrollment: 2024/10/28
• Target sample size: 8
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Insantaneous Extraction Ratio (ER) of Isosorbide Dinitrate in the lung.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: AST and ALT levels exceeding three times the upper limit of normal values. Serum creatinine levels exceeding 1.5 times the upper limit of normal values. Requirement for continuous oxygen therapy due to pulmonary disease. Decompensated heart failure at the time of consent. Patients diagnosed with severe valvular disease by echocardiography. Deemed unsuitable for this study by the investigator. Exclusion Criteria for Lab Values Obtained During Cardiac Catheterization Cardiac Index (CI) obtained by the thermodilution method is 1.8 L/min/m2 or below. Pulmonary Artery Wedge Pressure (PAWP) is 18 mmHg or higher. Pulmonary Vascular Resistance (PVR) calculated as (mean PAP - PAWP) / CO is 3.0 Wood or higher, or mean PAP is 25 mmHg or higher. A sheath could not be placed in the radial artery. The physician deems the administration of Isosorbide Dinitrate inappropriate due to reasons such as hypotension.

Related Information

• Primary Sponsor: Oita University
• Secondary Sponsor: Nagoya City University Department of Cardiology
• Source(s) of Monetary Support: JSPS KAKENHI Grant Number 22K06701