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

JRCT ID: jRCTs031220640

Registered date:16/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary Hypertension
• Date of first enrollment: 06/04/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Acute vasoreactivity test for pulmonary hypertension with off label use of INOflow as nitric oxide

Outcome(s)

• Primary Outcome: Incidence of major adverse events (hypotension, hypoxia due to pulmonary edema and methemoglobinemia)

Secondary Outcome

(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)
(2). Incidence of adverse events except hypotension, hypoxia due to pulmonary edema and methemoglobinemia

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Minatsuki shun