Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide

Exclusion Criteria

• •Have had a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin) for PAH added within (1) month of RHC.
• •Have any PAH medication except for anticoagulants discontinued within the week prior to RHC.
• •Have evidence of significant parenchymal lung disease as evidenced by pulmonary function tests within the last six months
• •CREST (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, telangiectasia) syndrome
• •Have a history of uncontrolled sleep apnea within three months of RHC.
• •Have a history of hemodynamically significant left-sided heart disease
• •Have evidence of left-sided heart disease
• •Have any other disease that is associated with pulmonary hypertension (e.g. congenital systemic-to-pulmonary shunt, sickle cell anemia, schistosomiasis).
• •Documented uncontrolled systemic hypertension as evidenced by systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
• •Have used prescription appetite suppressants within 3 months prior to wean/transition.
• •Have chronic kidney disease stage IV or worse or the requirement for dialysis.
• •Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
• •Have had an atrial septostomy.
• •Have anemia (hemoglobin \<10 g/dL), active infection or any other ongoing condition that would interfere with the interpretation of study assessments.
• •Have any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, renal dialysis, etc.).
• •Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial
• •Participant is pregnant or lactating
• •Significant, ongoing alcohol or drug abuse.