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 is to investigate the potential use of device-based measures as outcome-surrogates for clinical assessments in PAH-patients using the new Breelib nebulizer in a real life setting.
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 | Status | |
|---|---|---|
Locations Many Locations Many Locations, Germany | Status Recruiting | 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
- Changed 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
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
- Heart rates during baseline and observation periodTimeframe: Up to 3 months
Additional Information
Not Available
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