Heart Failure Clinical Trial
Official title:
The Role of Preoperative Use of Levosimendan in Ischemic Cardiac Patients Undergoing Major Abdominal Cancer Surgeries: A Prospective Randomized Study
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.
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.
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