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



Status:Completed
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/23/2018
Start Date:July 2014
End Date:November 2016

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A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring 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).

This study is being done to evaluate the efficacy of levosimendan compared with placebo in
reducing the co-primary endpoints of 30-day composite of all-cause death or use of mechanical
assist device (IABP, LVAD or ECMO) or the composite event rate of all-cause death,
perioperative MI, need for dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in
subjects with reduced ejection fraction undergoing cardiac surgery on CPB.

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 ultrafiltration).

- 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.
We found this trial at
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
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Boca Raton, Florida 33486
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
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800 Washington St
Boston, Massachusetts 02111
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1200 North Elm Street
Greensboro, North Carolina 27401
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
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1 Tampa General Cir
Tampa, Florida 33606
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Albany, New York 12208
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
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Ann Arbor, Michigan 48106
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Asheville, North Carolina 28801
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1215 Lee St
Charlottesville, Virginia 22903
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Grand Rapids, Michigan 49503
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80 Seymour St
Hartford, Connecticut 6102
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Indianapolis, Indiana 46237
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Lincoln, Nebraska 68526
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530 S Jackson St
Louisville, Kentucky 40202
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20 York St, N20 York St,
New Haven, Connecticut 06520
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New York, New York 10021
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630 W 168th St
New York, New York
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Oklahoma City, Oklahoma 73120
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4242 Dewey Ave
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