Trial Search Results

Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass

A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Tenax Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Levosimendan
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Documented LVEF ≤35% measured by ventriculogram, echocardiogram (ECHO), nuclear scan,
   or MRI within 60 days before surgery.

   - Scheduled or urgent 1) CABG surgery, 2)CABG with aortic valve surgery, 3) CABG with
   mitral valve surgery, or 4) mitral valve surgery with or without other valves

   - Surgery will employ CPB pump

   - Signed (by the subjects or their legally acceptable representatives) informed consent
   document indicating that they understand the purpose of and procedures required for
   the study and are willing to participate in the study

Exclusion Criteria:

   - Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive
   pericarditis, pericardial tamponade, or other conditions in which cardiac output is
   dependent on venous return.

   - Evidence of systemic bacterial, systemic fungal, or viral infection within 72 hours
   before surgery.

   - Dialysis at randomization (either hemodialysis, peritoneal dialysis, continuous
   venovenous hemofiltration, or ultrafilitration).

   - Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2.

   - Weight ≥ 170 kg.

   - Patients whose SBP cannot be managed to ensure SBP > 90 mmHg at initiation of study
   drug.

   - Heart rate ≥ 120 bpm, persistent for at least 10 minutes screening and unresponsive to
   treatment.

   - Hemoglobin < 80 g/L.

   - Serum potassium < 3.5 mmol/L and > 5.5 mmol/L at baseline.

   - A history of Torsades de Pointes.

   - Mechanical assist device (IABP, LVAD, ECMO) in the patient at the start of surgery or
   pre-planned to be inserted during surgery before coming off CPB.

   - Patients with aortal femoral occlusive disease that would prohibit use of IABP unless
   VAD or ECMO not available.

   - Liver dysfunction Child Pugh Class B or C

   - Patients having severely compromised immune function

   - Pregnant, suspected to be pregnant, or breast-feeding.

   - Received an experimental drug or used an experimental medical device in previous 30
   days.

   - Known allergic reaction or sensitivity to Levosimendan or excipients.

   - Received commercial Levosimendan within 30 days before the planned start of study
   drug.

   - Employees of the investigator or study center, with direct involvement in the proposed
   study or other studies under the direction of that investigator or study center, as
   well as family members of the employees or the investigator.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting