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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
Tufts
Boston, Massachusetts, United States
University Hospital
Cleveland, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs.
Adverse Event Severity \[through Day 30 Follow-Up Period\] Unanticipated Device Effects: any system malfunction, damage or NO2 threshold monitor alarms \[through discharge from Treatment Period\] Laboratory Tests: Hematology (CBC with differential), Chemistry (glucose, BUN, creatinine, sodium, potassium, carbon dioxide, creatinine kinase), Activated Clotting Test or Prothrombin Time, arterial blood gas, and methemoglobin. \[through discharge from Treatment Period\] Vital Signs: pulse, blood pressure, respiratory rate \[through discharge from Treatment Period\]
Time frame: through Day 30 Follow-up Period
Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation
Time frame: through Treatment Period
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