Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial

• Conditions: 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.

• Registration Number: EUCTR2007-002803-42-AT
• Lead Sponsor: niv.Clinic of Internal Medicine II, Department of Cardiology, Medical University of Vienna, Austria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-20
• Last Update Posted: 8 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

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) <2l/min/m2
d)Written informed consent at the time of initial screening in conscious patients. In unconscious patients the treating physician will judge eligibility and the patients have to sign informed consent after regaining consciousness according to the Austrian regulations.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified