An interventional study of levosimendan at a dose of 6 mcg/kg and milrinone at a dose of 50 mcg/kg in Hypertension, Pulmonary, Cardiac Failure and Pulmonary Vascular Resistance Abnormality, sponsored by Aretaieion University Hospital. Completed at 1 site in Greece. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Aretaieion University Hospital · Not applicable, Interventional, and Prevention
The aim of this study is to examine and compare the effect of Levosimendan and Milrinone administered intravenously and via inhalation respectively in cardiac surgery patients with pulmonary hypertension and right ventricular dysfunction.
Pulmonary hypertension (PH) is a pathophysiological disorder hemodynamically characterized by increased pulmonary vascular resistance and pressure. This can lead to right ventricle pressure overload and failure, which is worsened by cardiopulmonary bypass (CPB) and extracorporeal circulation and is accompanied by high rates of morbidity and mortality in cardiac surgery patients. Pharmacological agents used to decrease pulmonary vascular resistance and right ventricle afterload are prostaglandins, iloprost, milrinone, nitric oxide (NO) and recently Levosimendan. These agents can be administered intravenously or via inhalation.
In this study, the intravenous administration of Levosimendan will be compared with the inhalational use of milrinone in patients with pulmonary hypertension undergoing cardiac surgery.
In this setting, 40 patients with PH caused by left sided heart disease, will be assigned into two groups:
GROUP A: Intravenous administration of Levosimendan in dosage 6mcg/kg after induction of anesthesia.
GROUP B: Inhalational administration of milrinone in dosage 50mcg/kg after induction of anesthesia.
Before and after the administration of the drug, heart function will be evaluated by hemodynamic measurements obtained by the Swan-Ganz catheter. These parameters will be heart rate (HR), blood pressure (BP), mean pulmonary arterial pressure (MPAP), central venous pressure (CVP), cardiac output (CO), pulmonary capillary wedge pressure (PCWP), cardiac index (CI), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR). Transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE) will also be used.
This study will lead to conclusions regarding the effectiveness of intravenous administration of Levosimendan and inhalational use of Milrinone in the treatment of right heart failure and PH in cardiac surgery patients.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 40 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Aretaieion University Hospital is the lead sponsor of 34 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
in this group, 6 mcg/kg of levosimendan will be administered intravenously after anesthesia induction, aiming at prevention of pulmonary hypertension post bypass
Drug: levosimendan at a dose of 6 mcg/kg
in this group, 50 mcg/kg of milrinone will be administered via inhalation after anesthesia induction, aiming at prevention of pulmonary hypertension post bypass
Drug: milrinone at a dose of 50 mcg/kg
levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction
Also known as: Group Levo
milrinone will be administered via inhalation at a dose of 50 mcg/kg after anesthesia induction
Also known as: Group Milri
change from baseline in mean pulmonary arterial pressure (MPAP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in pulmonary vascular resistance (PVR)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in mean arterial pressure (MAP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in systemic vascular resistance (SVR)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in pulmonary capillary wedge pressure (PCWP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in cardiac output (CO)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in tricuspid annular plane systolic excursion (TAPSE)
transthoracic and transesophageal echocardiography will be used for echocardiographic measurements
Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
change from baseline in fractional area change
transthoracic and transesophageal echocardiography will be used for echocardiographic measurements
Time frame: 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission
length of ICU stay
duration of patient stay in ICU in days
Time frame: postoperatively, an average period of 7-10 days
hospitalization time
duration of hospital stay after surgery in days
Time frame: postoperatively, up to 20 days after the operation
Plan to share: No
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Aretaieion University Hospital