Registry to Prospectively Evaluate Use of Ventavis in Patients with Pulmonary Arterial Hypertension.

Study ID
Study00000129

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul

Contact
Lindsey Vacovsky
214-645-6488
lindsey.vacovsky@utsouthwestern.edu

Principal Investigator
Kelly Chin

Summary

The Ventavis(RegisteredTM) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension who have been receiving therapy with Ventavis(RegisteredTM) for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis(RegisteredTM) 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(RegisteredTM) adherence data.

At study entry, patient's treatment record for the preceding 3 months will be downloaded (the machine records use and treatment times; this is used in some cases clinically). Ventavis(RegisteredTM) treatment will then be measured at each visit, and the proportion completely adherent across all follow-up visits will be measured. Associations between baseline variables and adherence will be assessed using multivariable logistic regression.

Persistence with Ventavis(RegisteredTM) therapy will be evaluated using Kaplan-Meier product-limit estimates. Patients who cease to be persistent (defined as discontinuation of Ventavis(RegisteredTM) for 28 days or longer) will be censored at the time of last follow-up. Interventions will be assessed, controlling for baseline differences, using Cox proportional hazards models.

The target sample size of 300 patients will provide an estimate of adherence for the whole cohort with standard errors of less than 3%, and adherence for subgroups of interest (e.g. patients receiving a particular combination of interest) can be estimated with a standard error of 5% for subgroups comprising 100 patients or more.

Participant Eligibility

Prior to enrollment in the study, candidates must meet the following inclusion criterion at the time of screening:

* Have a current diagnosis of WHO Group I PAH

* Have initiated therapy with commercial Ventavis(RegisteredTM) using nebulizer (at least 3 months prior to study enrollment, either with commercial product or from participating in Actelion[Single Quote]s Clinical Study AC-063A320

* Age > 18 years old at the time of enrollment

* Signed informed consent