Pulmonary arterial hypertension (PAH) is associated with poor prognosis.The most common cause of death is right heart failure. The fact that right heart failure is associated with low systemic perfusion pressures limits the systemic use of potent vasodilators in this patient population. As a consequence, no therapeutic recommendations exist for patients experiencing right heart failure in the course of PAH.
Conditions
Interventions
Trade Name: Ventavis(Iloprost)
Product Name: Ventavis(Iloprost)
Pharmaceutical Form: Nebuliser solution
Sponsors
Univ.Clinic of Internal Medicine II, Department of Cardiology, Medical University of Vienna, Austria
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) PAH classification (according to "Pulmonary Hypertension-Executive Summary 2003, Venice" b) Echocardiographic and clinical signs of right heart failure, such as dyspnea, tachycardia, edema c) Mean right atrial pressure (mRAP) >15mmHg, cardiac index (CI) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Age younger than 18 years b) Right ventricular failure in the absence of PAH c) Pulmonary venous hypertension due to left-sided atrial, ventricular or valvular heart disease d) Known hypersensitivity to study drug or any ingredient e) Hypertrophic obstructive cardiomyopathy f) Significant aortic stenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): • Changes from baseline in cardiac output, right atrial pressure, pulmonary arterial pressure, PVR, blood pressure and heart rate and respiratory rate at 24h • Changes from baseline in lactate, brain natriuretic peptide, troponin T, and mixed venous and arterial oxygen saturation and PaCO2 at 24h • ICU length of stay • Safefety: An adverse event is any event during the clinical study, which impairs or further deteriorates the clinical condition of the patient; it may also take the form of an abnormal laboratory value. The term adverse event does not imply a causal relationship with the study treatment. All patients experiencing adverse events- whether considered associated with the use of the study medication or not- will be monitored until symptoms subside and any abnormal laboratory values have returned to baseline, or until there is satisfactory explanation for the changes observed, or until death, in which case a full pathologist’s report will be supplied, if possible. All findings must be reported on an “Adverse event“ page in the case record form. All adverse events will be reported and documented as described below. Adverse events are divided into the categories serious and nonserious. This determines the procedure, which must be used to report/document the adverse event (see below). Definition of serious and nonserious adverse events. A serious adverse event is: a) any event that is fatal or life –threatening b) any event that is permanently disabling c) any event that prolongs hospitalization d) any event that involves cancer, congenital anomaly, or occurs as a result of overdose (application of more than the stipulated dose) Adverse events, which do not fall into these categories, are defined as nonserious. ;Main Objective: In contrast to other vasodilators used for the treatment of PAH, inhaled iloprost reduces pulmonary arterial pressure without affecting the systemic circulation and may be used for right heart failure.;Secon | — |
Countries
Austria
Outcome results
None listed