Pulmonary Hypertension
Conditions
Keywords
Pulmonary Hypertension
Brief summary
The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.
Interventions
DRUGIloprost (Ventavis BAYQ6256)
Patients with pulmonary arterial hypertension, classified as New York Heart Association functional class III or IV where the treating physician has chosen Ventavis as a suitable treatment prior to inclusion into this non-interventional study. Patients should not have received prior treatment with Ventavis
Sponsors
Bayer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The treating physician has chosen Ventavis as a suitable treatment for the patient * Patient with PH and classified as NYHA functional class III or IV and WHO group 1
Exclusion criteria
* Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis patient package insert).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is 6-minute walking distance | At baseline and month 1,3,6 for an observational period of 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Hemodynamic parameters | If applicable ( at any time during Ventavis treatment) |
| Adverse Event collection | If applicable (during the study period) |
| New York Heart Association functional class | Baseline, month 1,3,6 |
| PH-related symptoms and change of concomitant medication | Baseline, month 1,3,6 |
Countries
South Korea
Outcome results
None listed