Efficacy of Ventavis Used in Real-life Setting.
Completed
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Drug: Inhaled iloprost (Ventavis, BAYQ6256)
- Registration Number
- NCT01355380
- Lead Sponsor
- Bayer
- Brief Summary
This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.
Typical clinical measures and quality of life will be prospectively followed in 12 months period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
- Pulmonary arterial hypertension in WHO functional class III or IV
- Age 18+
- Patients newly treated with Ventavis or switched from sildenafil
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Exclusion Criteria
- Retrospective documentation is not allowed
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Inhaled iloprost (Ventavis, BAYQ6256) Drug (incl. Placebo)
- Primary Outcome Measures
Name Time Method Changes of the exercise capacity as measured by 6-minutes walking distance 3, 6, 9 and 12 months vs. baseline
- Secondary Outcome Measures
Name Time Method Changes of depression score over time 3, 6, 9 and 12 months vs. baseline Changes of functional capacity as measured by WHO classification system 3, 6, 9 and 12 months vs. baseline Changes of pulmonary haemodynamics 3, 6, 9 and 12 months vs. baseline Changes of serum level of natriuretic peptide B 3, 6, 9 and 12 months vs. baseline Changes of Quality of Life score 3, 6, 9 and 12 months vs. baseline Changes in cardiac echo parameters 3, 6, 9 and 12 months vs. baseline Number of patients with treatment-emergent adverse events Up to 12 months