Pulmonary arterial hypertension
Conditions
Interventions
During right heart catheterization of patients with pulmonary hypertension, inhalation of nitric oxide at a concentration of 20 ppm will be performed for 10 minutes under room air using a nitric oxide
Nitric oxide delivery system (INOvent DS)
Sponsors
Minatsuki shun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Primary Registration] (1) Individuals suspected of pulmonary hypertension by echocardiography performed within 3 months (tricuspid regurgitation velocity >= 2.8 m/sec), or those already diagnosed with pulmonary hypertension. (2) Individuals scheduled for right heart catheterization for definitive diagnosis or disease status evaluation of pulmonary hypertension. (3) Age: Individuals aged >= 18 years at the time of informed consent. (4) Gender: Not specified. (5) Individuals who have provided voluntary written informed consent after receiving sufficient explanation and achieving full understanding for participation in this study. [Secondary Registration] (1) Individuals with mean pulmonary artery pressure >= 21 mmHg via right heart catheterization. (2) Individuals diagnosed with Group 1 pulmonary hypertension (pulmonary arterial hypertension; PAH). (3) Individuals newly starting monotherapy or combination therapy with endothelin receptor antagonists or phosphodiesterase inhibitors as therapeutic agents for pulmonary hypertension.
Exclusion criteria
Exclusion criteria: [Primary Registration] (1) Individuals with WHO Functional Class IV pulmonary hypertension. (2) Individuals with systolic blood pressure = 50 mmHg via right heart catheterization. (4) Others judged inappropriate for participation based on conditions or results during right heart catheterization by the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regression coefficient for the change in mean pulmonary artery pressure during nitric oxide inhalation (delta mPAP(NO)) measured at the initial right heart catheterization, adjusted for the baseline mean pulmonary artery pressure, in relation to mean pulmonary artery pressure after 3 months of guideline-compliant treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Regression and correlation coefficients for the changes in each hemodynamic index after 3 months of pulmonary hypertension treatment, both adjusted for baseline values, relative to the corresponding changes during nitric oxide inhalation measured at the initial right heart catheterization. (2) Difference in the change in mean pulmonary artery pressure after 3 months between groups with high and low nitric oxide-induced changes in mean pulmonary artery pressure. (3) Pre-administration and post-administration values, as well as the amount and rate of change, of each hemodynamic index measured by right heart catheterization before and after administration of inhaled nitric oxide. (4) Incidence rate of major complications (total of hypotensive events, hypoxemia associated with pulmonary edema, and methemoglobinemia) occurring during nitric oxide inhalation. (5) Frequency and rate of adverse events (excluding hypotensive events, hypoxemia associated with pulmonary edema, and methemoglobinemia) occurring during nitric oxide inhalation | — |
Contacts
Public ContactSatoshi Ishii
The University of Tokyo Hospital
Outcome results
None listed