Pulmonary Hypertension Pulmonary Hypertension
Conditions
Interventions
Acute vasoreactivity test for pulmonary hypertension with off label use of INOflow as nitric oxide
Nitric Oxide
Sponsors
Minatsuki shun
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major adverse events (hypotension, hypoxia due to pulmonary edema and methemoglobinemia) | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Contacts
Public ContactSatoshi Ishii
The University of Tokyo Hospital
Outcome results
None listed