Status:
COMPLETED
Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension
Lead Sponsor:
Bayer
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18+ years
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 B...
Eligibility Criteria
Inclusion
- 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
- Patients allergic to Nickel and Methacrylates
- Patients participating in an investigational program with interventions outside of routine clinical practice
Key Trial Info
Start Date :
February 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 20 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03293407
Start Date
February 1 2018
End Date
January 20 2020
Last Update
May 26 2021
Active Locations (1)
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1
Many Locations
Multiple Locations, Germany