Treatment of Pulmonary Hypertension in High-risk Cardiac Surgery Patients Using Inhalational and Intravenous Agents

Last updated: July 21, 2025
Sponsor: Aretaieion University Hospital
Overall Status: Completed

Phase

N/A

Condition

Heart Failure

Stress

Circulation Disorders

Treatment

milrinone at a dose of 50 mcg/kg

levosimendan at a dose of 6 mcg/kg

Clinical Study ID

NCT04718350
levo-milri
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with pulmonary hypertension due to left ventricular dysfunction based onechocardiographic diagnosis preoperatively

  • elective cardiac surgery

Exclusion

Exclusion Criteria:

  • primary pulmonary hypertension

  • thromboembolic disease

  • chronic obstructive pulmonary disease

  • emergency surgery

  • redo surgery

  • inability to consent to the study

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: milrinone at a dose of 50 mcg/kg
Phase:
Study Start date:
January 27, 2021
Estimated Completion Date:
December 30, 2023

Study Description

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.

Connect with a study center

  • Onassis Cardiac Surgery Center

    Athens, 17674
    Greece

    Site Not Available

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