Observational description of Compliance for the daily Ventavis use via the Insight program in class III Pulmonary Arterial Hypertension patients (DAILY)
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.
- 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
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
Many Locations, France
E-mail: [email protected]
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DAILY: Observational description of Compliance for the daily Ventavis® use via the Insight program in class III Pulmonary Arterial Hypertension patients