Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension

• Status: Completed
• Trial end date: 2018-10-24
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective

• To evaluate the effect of rapid inhalation of 2.5μgiloprost using the Breelib nebulizer on pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension

Secondary objectives

• To evaluate the effect of rapid iloprost inhalation using the Breelib nebulizer on mean pulmonary arterial pressure (mPAP), cardiac output (CO), cardiac index (CI), systemic blood pressure, arterial oxygen saturation, heart rate, and pulmonary arterial wedge pressure (PAWP).

• To evaluate the safety and tolerability of the rapid iloprost inhalation using the Breelib nebulizer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Giessen
• Treatments: Iloprost

Criteria

Inclusion Criteria:

• Confirmed diagnosis of pulmonary arterial hypertension, WHO group 1 diagnosed according to current guidelines

• New York Heart Association functional class III

• mPAP ≥ 25 mmHg, PAWP ≤ 15 mmHg

• Age ≥ 18 years; ≤ 85 years

• planned right heart catheterization based on clinical grounds

• Stable specific PAH medications other than prostanoids

• Signed informed consent

Exclusion Criteria:

• other etiologic groups of pulmonary hypertension (WHO group 2, 3, 4, 5)

• Unstable or severe coronary artery disease (history of cardiac surgery, history of coronary intervention 2 years prior to inclusion), uncontrolled arterial hypertension, severe left ventricular hypertrophy, severe congenital or acquired valvular or myocardial disease, systolic blood pressure < 90 mmHg, heart rate of <55 or >105 beats·min-1 before inhalation

• Progressive left heart failure History of severe ventricular arrhythmias

• Pulmonary veno-occlusive disease

• Transitory ischemic attack (TIA) or stroke ≤ 3months

• Severe hepatic impairment (> CHILD B)

• Severe, terminal renal impairment

• Use of intravenous, subcutaneous or oral prostacyclin/IP receptor agonists

• Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results