Trial Condition(s):
Hypertension, Pulmonary
Evaluation of inhaled iloprost effects using the Breelib nebulizer, on clinical outcomes and physical activity of patients with advanced pulmonary arterial hypertension (VENTASTEP)
Bayer Identifier:
19398
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Ventavis® (Iloprost): Evaluation of inhaled iloprost effects using the Breelib™ nebulizer, on clinical outcomes and physical activity of patients with advanced pulmonary arterial hypertension
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Change of Six-minute walking distance (6MWD)Clinical outcome measured by study nurse.Timeframe: Baseline and 3 months
- Change of laboratory results of the biomarkers NT-pro BNP/BNPTimeframe: Baseline and 3 months
- Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D)Timeframe: Baseline and 3 months
- Change of World Health Organization functional classTimeframe: Baseline and 3 months
- Change of Distance Walked per dayTimeframe: Baseline and 3 months
- Change of Number of Steps per dayTimeframe: Baseline and 3 months
- Change of number of floors climbed (10 feet) per dayTimeframe: Baseline and 3 months
- Change of time spent at home per dayTimeframe: Baseline and 3 months
- Change of number of relevant location changes per dayTimeframe: Baseline and 3 months
- Change of number of times leaving home per dayTimeframe: Baseline and 3 months
- Change of number of times standing up per dayTimeframe: Baseline and 3 months
- Change of 6MWDDevice based outcome measured by smart device.Timeframe: Baseline and 3 months
- Heart rates during baseline and observation periodTimeframe: Up to 3 months
Secondary Outcome
- The average daily inhalation duration per sessionTimeframe: Up to 3 months
- The average number of daily inhalationsTimeframe: Up to 3 months
- Change of sleep qualityMeasured by Pittsburgh Sleep Quality Index (PSQI).Timeframe: Baseline and 3 months
- Incidence of AEsTimeframe: Up to 3 months after first inhalation
- Change of heart rate during 6MWDTimeframe: Baseline and 3 months
- The average daily proportion of complete/incomplete inhalationsTimeframe: Up to 3 months
- The average association between physical activity level (wearable device based) and time to last inhalationTimeframe: Up to 3 months
Additional Information
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