Hypertension, Pulmonary
Conditions
Keywords
Non-interventional, Ventavis, Iloprost, Pulmonary hypertension, Compliance, Russian Federation
Brief summary
Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.
Interventions
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients ≥ 18 years old * Diagnosis of PH * Planned or current treatment with Ventavis (not more than 6 month)
Exclusion criteria
* Contraindications for the use of Ventavis in accordance with the local product information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days without any drug administration at all | Up to 12 months |
| Number of fully inhaled doses in relation to the total number of inhalations per day | Up to 12 months |
| Number of missed doses per day as recommended | Up to 12 months |
| Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label | Up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the structural changes in the lungs using spirography | Up to 12 months |
| Assessment of lung haemodynamics using the data of echocardiography | Up to 12 months |
| Assessment of lung haemodynamics using the data of catheterization | Up to 12 months |
| Reason for omission of inhalation as assessed by the physician | Up to 12 months |
| Concomitant medication for other indications than pulmonary hypertension | Up to 12 months |
| 6 minute walking distance test (MWDT) value | Up to 12 months |
| Severity of AEs | Up to 12 months |
| AE relation to treatment | Up to 12 months |
| AE treatment | Up to 12 months |
| AE outcomes | Up to 12 months |
| Number of participants with adverse events (AEs) | Up to 12 months |
| Score on dyspnea Borg CR (category ratio) 10 scale | Up to 12 months |
| Patients' quality of life, assessed by validated questionnaire | Up to 12 months |
| Assessment of the structural changes in the lungs using X-ray examination of the lungs | Up to 12 months |
Countries
Russia
Outcome results
None listed