Levosimendan Administration in Pulmonary Hypertension
Condition: Hypertension, Pulmonary; Cardiac Failure; Pulmonary Vascular Resistance Abnormality
MeSH terms: Hypertension, Pulmonary; Hypertension; Heart Failure
Study type: Interventional

Summary: 
      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.
    

Detailed 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, 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.
    

Intervention name(s): levosimendan at a dose of 3 mcg/kg; levosimendan at a dose of 6 mcg/kg; levosimendan at a dose of 12 mcg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): levosimendan will be administered intravenously at a dose of 3 mcg/kg after anesthesia induction; levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction; levosimendan will be administered intravenously at a dose of 12 mcg/kg after anesthesia induction
Intervention MeSH terms: Simendan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pulmonary vascular resistance; pulmonary hypertension; vasodilators; cardiopulmonary bypass