Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

• Status: Completed
• Trial end date: 2017-01-16
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Iloprost

Criteria

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