Status:
COMPLETED
Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
Lead Sponsor:
University of Giessen
Conditions:
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Se...
Detailed Description
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. Patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03365479
Start Date
May 1 2017
End Date
October 24 2018
Last Update
October 26 2018
Active Locations (2)
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1
University Clinic Giessen and Marburg
Giessen, Hesse, Germany, 35392
2
Kerckhoff-Klinik
Bad Nauheim, Germany