Pulmonary Arterial Hypertension
Conditions
Keywords
pulmonary arterial hypertension, Ventavis®, iloprost
Brief summary
The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis® adherence data.
Detailed description
The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH and who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. All data will be collected via patient interview and/or review of the medical record, as well as from I-neb® downloads using INSIGHT software. Adherence with Ventavis® will be compared before and after targeted instruction on inhalation techniques by a respiratory therapist or designee, as well as before and after participation in PAH patient support groups (if applicable). Quarterly data collection will include capture of PAH and non-PAH medications and Ventavis® adherence data; Ventavis® adherence data will also be collected one month after study entry.
Interventions
Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6)
Sponsors
Study design
Eligibility
Inclusion criteria
1. Have a current diagnosis of WHO Group I PAH 2. Have initiated therapy with commercial Ventavis® administered via portable nebulizer at least 3 months prior to study enrollment, either with commercial product or from participation in Actelion's Clinical Study AC-063A302 3. Age \> or = 18 years old at the time of enrollment
Exclusion criteria
1. Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH 2. Are not currently on commercial Ventavis® 3. Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence with instructions for use of Ventavis® | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Persistence of use of Ventavis® | 2 years |