Hypertension, Pulmonary
Conditions
Keywords
Pulmonary arterial hypertension, PAH
Brief summary
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.
Interventions
Using Breelib device
DEVICEBreelib nebulizer
Used for inhalation of Ventavis
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
* Ventavis-treatment naïve patients aged ≥18 years at initiation of Ventavis (Iloprost) therapy diagnosed with pulmonary arterial hypertension WHO FC III * Patients who are planned to be treated with Ventavis (Iloprost) and where the decision to use the Breelib has been agreed by physician and patient * Patients who are willing to wear a smart watch (iWatch2) over the observation period of 3 months ± 2 weeks * Signed informed consent
Exclusion criteria
* Patients allergic to Nickel and Methacrylates * Patients participating in an investigational program with interventions outside of routine clinical practice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rates during baseline and observation period | Up to 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 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 | — |
| Change of number of times standing up per day | Baseline and 3 months | — |
| Change of 6MWD | Baseline and 3 months | Device based outcome measured by smart device. |
| Change of number of floors climbed (10 feet) per day | Baseline and 3 months | — |
| Change of Six-minute walking distance (6MWD) | Baseline and 3 months | Clinical outcome measured by study nurse. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The average number of daily inhalations | Up to 3 months | — |
| Change of sleep quality | Baseline and 3 months | Measured by Pittsburgh Sleep Quality Index (PSQI). |
| 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 | — |
| The average daily inhalation duration per session | Up to 3 months | — |
Countries
Germany
Outcome results
None listed