Safety Assessment For Acute Vasoreactivity Test Using Inhaled Nitric Oxide Delivery System In Pulmonary Hypertensio

Phase 2

Recruiting

• Conditions: Pulmonary Hypertension

• Registration Number: JPRN-jRCTs031220640
• Lead Sponsor: Minatsuki shun

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

[Primary Enroll]
(1). Suspected of pulmonary hypertension (tricuspid regurgitation velocity >= 2.8 m/s) or diagnosed with pulmonary hypertension (mean pulmonary artery pressure >= 21 mmHg)
(2). Scheduled to have a right heart catheterization to diagnose or evaluate pulmonary hypertension
(3). Aged 18 years and above at the time of informed consent is taken
(4). Male or female
(5). Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation
[Secondary Enroll]
(1). Mean pulmonary artery pressure >= 21 mmHg measured by right heart catheterization

Exclusion Criteria

[Primary Enroll]
(1). With pulmonary hypertension with a WHO functional class IV
(2). Systolic blood pressure <= 90 mmHg
(3). Resting room air SpO2 <= 90%
(4). Unable to give written informed consent (e.g. impaired consciousness, mental disorder)
(5). Judged as ineligible by clinical investigators
[Secondary Enroll]
(1). Systolic blood pressure <= 90 mmHg during the right heart catheterization
(2). Resting room air SpO2 <= 90% during the right heart catheterization
(3). Judged as ineligible by clinical investigators according to the state or the result of the right heart catheterization

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of major adverse events (hypotension, hypoxia due to pulmonary edema and methemoglobinemia)

Secondary Outcome Measures

Name	Time	Method
(1). Values, changes and change rates of hemodynamics measured by right heart catheterization before and after acute vasoreactivity test; right atrial pressure, right ventricular pressure, pulmonary artery pressure, pulmonary capillary wedge pressure and cardiac output (thermodilution and Fick-method)<br>(2). Incidence of adverse events except hypotension, hypoxia due to pulmonary edema and methemoglobinemia