Clinical Trial: Levosimendan Versus Dobutamine for Renal Function in Heart Failure

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Efficacy of Intravenous Levosimendan Compared With Dobutamine on Renal Hemodynamics and Function in Chronic Heart Failure

Brief Summary: Although inotropes have a favorable effect on central hemodynamics in patients with heart failure, their effect on renal hemodynamics is incompletely defined. The purpose of this study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is that patients treated with levosimendan will show greater increases in renal blood flow and glomerular filtration rate (GFR) than those treated with dobutamine.

Detailed Summary:
Sponsor: Göteborg University

Current Primary Outcome:

  • Change in renal blood flow [ Time Frame: 75 min minus baseline ]
    Para-aminohippuric acid (PAH) infusion clearance
  • Change in glomerular filtration rate [ Time Frame: 75 min minus baseline ]
    Chrome-ethylenediaminetetraacetic acid (EDTA) infusion clearance


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in renal vascular resistance [ Time Frame: 75 min minus baseline ]
    Renal blood flow divided by the difference between renal arterial pressure and renal venous pressure
  • Change in central hemodynamics [ Time Frame: 75 min minus baseline ]
    Right atrial pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, mean arterial pressure, cardiac output, pulmonary vascular resistance and systemic vascular resistance measured with a pulmonary artery thermodilution catheter.
  • Change in renal oxygen consumption and oxygen extraction [ Time Frame: 75 min minus baseline ]

    Oxygen consumption: Renal blood flow multiplied by arterial-renal venous oxygen difference.

    Oxygen extraction: Ratio of renal oxygen consumption to renal oxygen delivery

  • Change in filtration fraction [ Time Frame: 75 min minus baseline ]
    Ratio of glomerular filtration rate to renal plasma flow


Original Secondary Outcome: Same as current

Information By: Göteborg University

Dates:
Date Received: May 5, 2014
Date Started: April 2014
Date Completion: December 2017
Last Updated: February 1, 2017
Last Verified: February 2017