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| ID | Type | Description | Link |
|---|---|---|---|
| VE1311RU | Other Identifier | Company internal |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iloprost | The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost (Ventavis, BAYQ6256) | Drug |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walking distance test (MWDT) value | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients ≥ 18 years old with PH, treated with Ventavis and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Russia |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Up to 12 months |
| Assessment of the structural changes in the lungs using X-ray examination of the lungs | Up to 12 months |
| 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 |
| Number of participants with adverse events (AEs) | 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 |
| D002318 |
| Cardiovascular Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |