Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass (LEVO-CTS)

May 22, 2018 updated by: Tenax Therapeutics, Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
882

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • Institute Universitaire de Cardiologie et Pneumologie de Quebec
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • British Columbia
      • Victoria, British Columbia, Canada
        • Royal Jubilee Hospital (Vancouver Island Health Authority)
      • Victoria, British Columbia, Canada
        • Victoria Heart Institute Foundation
    • Manitoba
      • Winnepeg, Manitoba, Canada
        • St. Boniface Hospital
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Health Sciences
      • London, Ontario, Canada
        • London Health Sciences Center, University Hospital
      • Newmarket, Ontario, Canada
        • Southlake Regional Health Center
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Heart Institute
      • Montreal, Quebec, Canada
        • McGill University Health Centre-Royal Victoria Hospital
  • United States
    • Alabama
      • Burlington, Alabama, United States
        • University of Alabama at Burlington Hospital
      • Huntsville, Alabama, United States
        • Huntsville Hospital
    • California
      • Sacramento, California, United States
        • Mercy General Hospital
      • San Diego, California, United States
        • University of California San Diego Medical Center
      • Stanford, California, United States
        • Stanford University School of Medicine
    • Connecticut
      • Hartford, Connecticut, United States
        • Hartford Hospital
      • New Haven, Connecticut, United States
        • Yale-New Haven Hospital
    • Florida
      • Boca Raton, Florida, United States
        • Boca Raton Community Hospital
      • Gainesville, Florida, United States
        • Shands Hospital at the University of Florida
      • Tampa, Florida, United States
        • Tampa General Hospital
    • Georgia
      • Rome, Georgia, United States
        • Redmond Regional Medical Center
    • Illinois
      • Evanston, Illinois, United States
        • Northwestern University Hospital
    • Indiana
      • Fort Wayne, Indiana, United States
        • Lutheran Hospital of Indiana
      • Indianapolis, Indiana, United States
        • Franciscan St. Francis Health
    • Iowa
      • West Des Moines, Iowa, United States
        • Iowa Heart Center/ Mercy Medical Center
    • Kentucky
      • Louisville, Kentucky, United States
        • University of Louisville Hospital
    • Maine
      • Portland, Maine, United States
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States
        • St. Joseph's Mercy Hospital
      • Dearborn, Michigan, United States
        • Oakwood Hospital and Medical Center
      • Grand Rapids, Michigan, United States
        • Spectrum Health
    • Missouri
      • Kansas City, Missouri, United States
        • St. Luke's Hospital
      • Saint Louis, Missouri, United States
        • Barnes Jewish Hospital
    • Nebraska
      • Lincoln, Nebraska, United States
        • Nebraska Heart Institute
      • Omaha, Nebraska, United States
        • Nebraska Medical Center
    • New Jersey
      • Morristown, New Jersey, United States
        • Morristown Medical Center
    • New York
      • Albany, New York, United States
        • St. Peter's Hospital
      • New York, New York, United States
        • Columbia University Medical Center
      • New York, New York, United States
        • Mount Sinai Medical Center
      • New York, New York, United States
        • Lenox Hill Hospital
      • Roslyn, New York, United States
        • Saint Francis Hospital/The Heart Center
    • North Carolina
      • Asheville, North Carolina, United States
        • Mission Hospital
      • Greensboro, North Carolina, United States
        • Moses H. Cone Memorial Hospital
      • Raleigh, North Carolina, United States
        • Duke University Hospital
    • Ohio
      • Cincinnati, Ohio, United States
        • The Christ's Hospital; Lindner Clinical Trial Center
      • Cleveland, Ohio, United States
        • Cleveland Clinic
      • Cleveland, Ohio, United States
        • Case Medical Center
      • Columbus, Ohio, United States
        • Ohio State University Hospital
      • Toledo, Ohio, United States
        • ProMedica Toledo Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Oklahoma Heart Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • LeHigh Valley Hospital
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States
        • St. Thomas Heart
    • Texas
      • Dallas, Texas, United States
        • Baylor Hospital
      • Plano, Texas, United States
        • The Heart Hospital Baylor Plano
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia Health System
    • Washington
      • Tacoma, Washington, United States
        • Franciscan Health System Res. Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Aurora Saint Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Levosimendan
levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours
Drug: Levosimendan
Other Names:
  • Simdax
Placebo Comparator: Placebo
placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours
Drug: Placebo
matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Dual Efficacy Endpoint Events
Time Frame: 30 days
The all-cause death at 30 days or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) through Day 5
30 days
Number of Quad Efficacy Endpoint Events
Time Frame: 30 days
Composite of all-cause death (at 30 days), or perioperative nonfatal MI [CK-MB >10xULN or >100 ng/mL, CK-MB >5xULN or 50 ng/mL with new Q wave (>0.04 seconds wide in two contiguous leads) or new left bundle branch block)] (through Day 5), or need for renal dialysis (through Day 30), or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) (through Day 5)
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Intensive Care Unit/Critical or Coronary Care Unit (ICU/CCU) (Days)
Time Frame: participants will be followed for during the participant's hospital stay up to 30 days
Duration of intensive care unit/critical or coronary care unit (ICU/CCU) length of stay (LOS) in days
participants will be followed for during the participant's hospital stay up to 30 days
Incidence of Low Cardiac Output Syndrome (LCOS)
Time Frame: 5 days
Use of a mechanical cardiac assist device within 5 days after surgery, two consecutive measurements of low cardiac output (defined as a cardiac output of ≤2.0 liters per minute per square meter of bodysurface area), one measurement of low cardiac output plus the use of two or more inotropes at or beyond 24 hours after surgery, or the use of two or more inotropes at or beyond 24 hours after surgery with the indicated reason being low cardiac output.
5 days
Postoperative Use of Secondary Inotrope
Time Frame: 24 hours
Use of (dobutamine, milrinone, epinephrine, dopamine) associated with index surgical procedure at 24 hours after initiation of surgery
24 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Occurrence of All-cause Mortality From Randomization Through Day 90
Time Frame: 90 days
90 days
Rehospitalization for Any Cause Through Day 30
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tenax Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rajendra Mehta, MD, Duke Clinical Research Institute
  • Study Chair: John Alexander, MD, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 1, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TNX-LVO-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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