Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Actelion
Age
3–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female, age 3-18 years
Diagnosis of PAH due to IPAH, connective tissue disease, or congenital heart disease
Pulmonary arterial hypertension confirmed by a cardiac catheterization, with mPAP \> 25 mmHg at rest, PCWP or LVEDP ≤ 15 mmHg, and PVR ≥ 240 dynes/sec/cm-5 (ie, ≥ 3.0 units m2)
NYHA/WHO functional Class II, III, or IV
Have had a 6-minute walk test (6-MWT) performed within the 3 months preceding the screening visit (if ≥ 8 years of age)
Have had cardiopulmonary exercise testing (CPET) performed within the 3 months preceding the screening visit (if ≥ 8 years of age and \> 130 cms in height. CPET testing will be conducted on NYHA/WHO Class IV patients at the discretion of the Principal Investigator)
If receiving therapy for PAH, on a stable dose and regimen for at least 3 months prior to the screening visit
If receiving digoxin, diuretic, or oxygen therapy, on a stable dose and regimen for at least 30 days preceding the screening visit
Must demonstrate the ability to appropriately use the nebulizer device as part of the screening process
You may not be if
Prior use of prostacyclins or prostacyclin analogues within 3 months prior to screening
Portal hypertension or clinically relevant hepatic disease
Eisenmenger syndrome with resting SpO2 \<88% on room air
Clinically relevant asthma or other chronic lung disease, such as bronchopulmonary dysplasia, cystic fibrosis, or repaired or unrepaired congenital diaphragmatic hernia
Diagnosis or current evidence of active lung infection or clinically relevant hemoptysis
Left-sided heart disease, including valvular disease or heart failure
Initiation or dosage adjustment of PAH-specific therapy within 3 months prior to screening
Initiation of treatment with digoxin, diuretics, anticoagulation, or oxygen therapy within 30 days prior to screening
Clareo Health | Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension
