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
Exclusion Criteria
- Retrospective documentation is not allowed
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of inhaled iloprost in pulmonary arterial hypertension?
How does inhaled iloprost compare to standard-of-care treatments for pulmonary arterial hypertension in observational studies?
Which biomarkers are associated with response to inhaled iloprost in pulmonary arterial hypertension patients?
What are the most common adverse events reported with Ventavis in real-life pulmonary arterial hypertension treatment settings?
Are there combination therapies involving iloprost that improve outcomes in pulmonary arterial hypertension compared to monotherapy?