Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years (OPTION)

Bayer

Status: Completed

Conditions: Pulmonary Hypertension

Treatments: Drug: Ventavis inhaled (Iloprost, BAYQ6256)

Study type: Observational

Funder types: Industry

Identifiers

NCT01389271

VE0910TR (Other Identifier)

14990

Details and patient eligibility

About

This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who has pulmonary hypertension treated with inhaled iloprost older than 18 years old.
• Primary (idiopathic and familial) pulmonary hypertension (PH) with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
• Pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
• Patients who signed written informed consent.

Exclusion criteria

• 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.
• Pregnancy and lactation
• Age below 18

Trial design

118 participants in 1 patient group

Group 1

Treatment:

Drug: Ventavis inhaled (Iloprost, BAYQ6256)