Skip to main content
OpenTrials
Completed

NCT Number: NCT04599816

Levosimendan Administration in Pulmonary Hypertension

The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension, Pulmonary Cardiac Failure Cardiovascular Diseases Heart Diseases Heart Failure Hypertension Lung Diseases Pulmonary Vascular Resistance Abnormality Respiratory Tract Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onassis Cardiac Surgery Center

Athens, 17674, Greece

About this study

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, Levosimendan will be administered in patients with pulmonary hypertension undergoing cardiac surgery. The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function. The drug will be administered in different doses to define the dose at which Levosimendan administration reduces pulmonary vascular resistance and pressure without causing significant reduction of systemic vascular resistance and pressure. The anti-inflammatory effect of the perioperative use of Levosimendan in cardiac surgery will also be studied.

In this setting, 45 patients with PH caused by left sided heart disease, will be assigned into three groups:

GROUP A: Administration of Levosimendan at a dosage of 3mcg/kg after anesthesia induction.

GROUP B: Administration of Levosimendan at a dosage of 6mcg/kg after anesthesia induction.

GROUP C: Administration of Levosimendan at a dosage of 12mcg/kg after anesthesia induction.

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. The anti-inflammatory action of Levosimendan will also be evaluated by interleukin-6 (IL-6) measurements.

This study will lead to conclusions regarding the effectiveness of Levosimendan administration in the treatment of right heart failure and PH in cardiac surgery patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively
  • elective cardiac surgery

Exclusion criteria

  • primary pulmonary hypertension
  • thromboembolic disease
  • chronic obstructive pulmonary disease
  • emergency surgery
  • redo surgery
  • inability to consent to the study

Treatment and study plan

levosimendan at a dose of 3 mcg/kg

Drug

levosimendan will be administered intravenously at a dose of 3 mcg/kg after anesthesia induction

levosimendan at a dose of 6 mcg/kg

Drug

levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction

levosimendan at a dose of 12 mcg/kg

Drug

levosimendan will be administered intravenously at a dose of 12 mcg/kg after anesthesia induction

Primary outcomes

  1. change from baseline in mean pulmonary arterial pressure (MPAP)

    Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

Secondary outcomes

  1. change from baseline in pulmonary vascular resistance (PVR)

    Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  2. change from baseline in mean arterial pressure (MAP)

    Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  3. change from baseline in systemic vascular resistance (SVR)

    Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  4. change from baseline in pulmonary capillary wedge pressure (PCWP)

    Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  5. change from baseline in cardiac output (CO)

    Time frame: 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission

    a Swan-Ganz catheter will be used for hemodynamic measurements

  6. change from baseline in tricuspid annular plane systolic excursion (TAPSE)

    Time frame: 20 minutes after levosimendan administration, at the end of surgery, 2 hours after Intensive Care Unit (ICU) admission and 80 hours after levosimendan administration

    transthoracic and transesophageal echocardiography will be used for echocardiographic measurements

  7. change from baseline in fractional area change

    Time frame: 20 minutes after levosimendan administration, at the end of surgery, 2 hours after Intensive Care Unit (ICU) admission and 80 hours after levosimendan administration

    transthoracic and transesophageal echocardiography will be used for echocardiographic measurements

Other outcomes

  1. change from baseline in blood levels of levosimendan

    Time frame: 20 minutes, 6 hours, 12 hours, 24 hours and 80 hours after administration

    blood levels will be measured with liquid chromatography

  2. change from baseline in blood levels of interleukin-6 (IL-6)

    Time frame: end of surgery, 6 hours, 12 hours and 24 hours after Intensive Care Unit (ICU) admission

    blood levels will be measured with the enzyme linked immunosorbent assay (ELISA)

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

Levosimendan Administration in High Risk Cardiac Surgery Patients With Pulmonary Hypertension

Acronym: Levosim-PH

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.