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The main aim of the observational VENTASTEP study was to investigate the association between changes in clinical outcome measures and changes in device outcome measures in PAH patients using the new Breelib nebulizer in a real life setting.
The study was not designed to investigate or confirm the effectiveness and safety of iloprost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAYQ6256_Ventavis | Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost (Ventavis, BAYQ6256) | Drug | Using Breelib device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Six-minute walking distance (6MWD) | Clinical outcome measured by study nurse. | Baseline and 3 months |
| Change of laboratory results of the biomarkers NT-pro BNP/BNP | Baseline and 3 months | |
| Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D) | Baseline and 3 months | |
| Change of World Health Organization functional class | Baseline and 3 months | |
| Change of Distance Walked per day | Baseline and 3 months | |
| Change of Number of Steps per day | Baseline and 3 months | |
| Change of number of floors climbed (10 feet) per day | Baseline and 3 months | |
| Change of time spent at home per day | Baseline and 3 months | |
| Change of number of relevant location changes per day | Baseline and 3 months | |
| Change of number of times leaving home per day | Baseline and 3 months | |
| Measure | Description | Time Frame |
|---|---|---|
| The average daily inhalation duration per session | Up to 3 months | |
| The average number of daily inhalations | Up to 3 months | |
| Change of sleep quality |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with pulmonary hypertension at intermediate risk and WHO FC III who failed to respond adequately to initial therapy with one or more PAH drugs or who clinically deteriorated after initial treatment response and for whom a therapy escalation with Ventavis (Iloprost) has been agreed by patient and physician.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30985279 | Background | Mueller C, Stollfuss B, Roitenberg A, Harder J, Richter MJ. Evaluation of Clinical Outcomes and Simultaneous Digital Tracking of Daily Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Protocol for the Observational VENTASTEP Study. JMIR Res Protoc. 2019 Apr 15;8(4):e12144. doi: 10.2196/12144. | |
| 34623313 |
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| Breelib nebulizer |
| Device |
Used for inhalation of Ventavis |
|
| Change of number of times standing up per day |
| Baseline and 3 months |
| Change of 6MWD | Device based outcome measured by smart device. | Baseline and 3 months |
| Heart rates during baseline and observation period | Up to 3 months |
Measured by Pittsburgh Sleep Quality Index (PSQI). |
| Baseline and 3 months |
| Incidence of AEs | Up to 3 months after first inhalation |
| Change of heart rate during 6MWD | Baseline and 3 months |
| The average daily proportion of complete/incomplete inhalations | Up to 3 months |
| The average association between physical activity level (wearable device based) and time to last inhalation | Up to 3 months |
| Derived |
| Stollfuss B, Richter M, Dromann D, Klose H, Schwaiblmair M, Gruenig E, Ewert R, Kirchner MC, Kleinjung F, Irrgang V, Mueller C. Digital Tracking of Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Observational Study (VENTASTEP). J Med Internet Res. 2021 Oct 8;23(10):e25163. doi: 10.2196/25163. |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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