Conditions: Pulmonary Arterial Hypertension
Keywords: Diagnostic Techniques and Procedures
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

Brief summary:
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will receive inhaled nitric oxide in oxygen or nitric oxide in air delivered by nasal cannula. Hemodynamics, clinical laboratory and clinical assessment data will be collected on all participants to evaluate safety.

Detailed description:
TREATMENT/FOLLOW-UP:

Participants meeting eligibility criteria will receive open label nitric oxide at 80 ppm via a nasal cannula. Hemodynamic clinical laboratory and clinical assessment data will be collected at baseline, after 15 minutes of inhaled nitric oxide administration, post RHC procedure and at hospital discharge. Day 5 +/- 3 post RHC, telephone contact to assess general health status.

Arms:
arm 1: Nitric Oxide via GeNO Nitrosyl system

Interventions: intervention 1: Nitric Oxide generated by the GeNO nitrosyl delivery system
Intervention descriptions: intervention 1: single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.

Protocol document: