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

NCT02025621 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 882

Last updated 2018-06-21

Study results available
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Summary

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).

Conditions

  • Coronary Artery Bypass Grafting
  • Mitral Valve Surgery
  • Low Cardiac Output Syndrome

Interventions

DRUG

Levosimendan

DRUG

Placebo

matching placebo

Sponsors & Collaborators

  • Tenax Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Rajendra Mehta, MD · Duke Clinical Research Institute

  • John Alexander, MD · Duke Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025621 on ClinicalTrials.gov