Investigation of mechanisms of pulmonary hypertension due to left heart disease

JRCT ID: jRCTs041180123

Registered date:23/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 01/07/2016
• Target sample size: 100
• Study type: Interventional

Intervention(s)

A Rho-kinase inhibitor is administered over a period of 30
minutes during cardiac catheterization

Outcome(s)

• Primary Outcome: Changes in pulmonary vascular resistance in response to Fasudil administration in reactive pulmonary hypertension.

Secondary Outcome

Changes in pulmonary vascular resistance in response to Fasudil administration in passive pulmonary hypertension.
Changes in cardiac index in response to Fasudil administration in reactive and passive pulmonary hypertension.
Changes in mean pulmonaryarterial pressure in response to Fasudil administration in reactive and passive pulmonary hypertension.
Changes in cyclic GMP in response to Fasudil administration in reactive and passive pulmonary hypertension.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Heart Failure due to left heart disease with NYHA classifications 2-4

Exclude criteria

1. Severe primary valvular heart disease
2. Acute coronary syndrome
3. Cardiogenic shock
4. Mechanical ventilation
5. Pulmonary hypertension except for Group 2
6. Connective tissue disease
7. Stage 5 chronic kidney disease
8. Active Pneumonia
9. Life expectancy less than 1 year due to malignant disease
10. Pregnancy
11. Others not applicable person determined by a doctor

Related Information

• Primary Sponsor: Dohi Kaoru
• Source(s) of Monetary Support: Japan society for the promotion of science
• Secondary ID(s): 000025460