Pulmonary Arterial Hypertension
Conditions
Keywords
Iloprost Compliance
Brief summary
This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.
Interventions
Initial dose: 2.5 µg per inhalation session; 6-9 inhalations/day. Dose can be increased to up to 5.0 µg per inhalation session.
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
* Male or female subjects aged ≥18 years * Newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I Neb AAD device for the application, as described in the SmPC (Summary of Product Characteristics), complemented by the Insight * With Pulmonary Arterial Hypertension, Group I of the Dana point Pulmonary Hypertension Classification. * WHO (World Health Organization) /NYHA (New York Heart Association) Functional class III * Able and willing to give written informed consent for participation in the study
Exclusion criteria
Key contra indications: * Hypersensitivity to the active substance or to any of the excipients. * Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage). * Severe coronary heart disease or unstable angina; * Myocardial infarction within the last six months; * Decompensated cardiac failure if not under close medical supervision; * Severe arrhythmias; * Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months. * Pulmonary hypertension due to venous occlusive disease. * Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compliance for each subject assessed by the mean daily number of inhalations of Ventavis. | Up to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test | 6 and 12 months | — |
| Dyspnea Borg Category Ration 10 Scale values | 6 and 12 months | — |
| Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires) | 6 and 12 months | — |
| Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale | Up to 12 months | — |
| Population characteristics | At baseline | sociodemography, clinical aspects, risk factors |
| Compliance for each subject assessed by the mean daily number of inhalations of Ventavis | Up to 6 months | — |
Other
| Measure | Time frame |
|---|---|
| Adverse events | Up to 12 months |
Countries
France
Outcome results
None listed