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

• Register: EUCTR
• Last refreshed on: 8 April 2013
• Main ID: EUCTR2007-002803-42-AT
• Date of registration: 20/02/2008
• Prospective Registration: Yes
• Primary sponsor: Univ.Clinic of Internal Medicine II, Department of Cardiology, Medical University of Vienna, Austria
• Public title: Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial
• Scientific title: Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial
• Date of first enrolment: 05/03/2008
• Target sample size: 8
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002803-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria

Key inclusion & exclusion 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) <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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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.

Intervention(s)

Trade Name: Ventavis(Iloprost)
Product Name: Ventavis(Iloprost)
Pharmaceutical Form: Nebuliser solution

Primary Outcome(s)

Secondary Objective:

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.

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.

Secondary ID(s)

15.05.2007