Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer Surgeries
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this pilot study is to evaluate the efficacy and safety of preoperative
      administration of levosimendan in patients with chronic heart failure scheduled for major
      abdominal cancer surgery assuming the reduction of both perioperative morbidity and
      mortality.
    

Detailed description: 
      Cardiac complications are one of the most common causes of perioperative morbidity and
      mortality in patients undergoing non-cardiac surgery. Heart failure (HF) is an established
      risk factor for postoperative cardiac complications and mortality. The risk for postoperative
      mortality following major non-cardiac surgery is twice as that of patients with coronary
      artery disease (CAD) without HF. HF occurs in 1% to 6% of patients after major surgery, the
      risk being higher, between 6% and 25%, in patients with pre-existing cardiac conditions such
      as CAD, prior HF or valvular heart disease.

      Cardiovascular disease and cancer are among the leading causes of mortality worldwide. The
      number of patients presenting with both diseases concomitantly is likely to increase. Cardiac
      patients undergoing major abdominal cancer surgeries with substantial fluid shift, blood loss
      and severe hemodynamic instability are at higher risk for perioperative HF.Therefore,
      preoperative optimization of such patients is of paramount importance. Unfortunately,
      guidelines for the perioperative management and preparation of such patients have not been
      proposed. Besides, the prophylactic use of inotropic agents for preoperative optimization of
      patients at high risk for HF remains controversial owing to their potential to jeopardize the
      myocardial oxygen supply-demand balance or to induce dysrhythmias with an assumed higher
      mortality.

      Levosimendan is a calcium sensitizer with a positive inotropic action that has been shown to
      safely improve cardiac performance and hemodynamics in HF patients without increasing the
      myocardial oxygen demand or causing dysrrhythmias. The perioperative use of levosimendan for
      optimization of patients with HF has been reported in few studies with promising results,
      mainly for cardiac patients undergoing cardiac surgeries. However, the role of levosimendan
      has not been thoroughly evaluated in patients with chronic heart failure (CHF) undergoing
      major cancer surgery.

      The purpose of this prospective study is to evaluate the safety and efficacy of preoperative
      administration of levosimendan in patients with CHF scheduled for major abdominal cancer
      surgery.
    

Intervention name(s): Levosimendan; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Preoperative 24 hours infusion of levosimendan for chronic heart failure patients prior to major abdominal cancer surgeries.; Preoperative 24 hours infusion of normal saline for chronic heart failure patients prior to major abdominal cancer surgeries.
Other intervention name(s): drug group; control group
Intervention MeSH terms: Simendan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention