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

Launched by UNIVERSITY OF GIESSEN · Dec 1, 2017

Keywords

ClinConnect Summary

This study aims to investigate the acute hemodynamic and pharmacological effects of a single inhalation of Iloprost (2.5μg) during right heart catheterization (RHC) using the Breelib nebulizer. Patients with confirmed diagnosis of pulmonary arterial hypertension (PAH = WHO group 1), NYHA functional class III and with stable background pulmonary vasoactive treatment or treatment naïve PAH patients will be challenged with the iloprost inhalation dosage during RHC. As a proof-of concept design, the study will include consecutive PAH patients only challenged with a single administration of inha...

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Eligibility 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