Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Levosimendan Versus Dobutamine for Renal Function in Heart Failure (ELDOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02133105
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : February 25, 2020
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University

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.

Condition or disease Intervention/treatment Phase
Cardiorenal Syndrome Drug: Levosimendan Drug: Dobutamine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intravenous Levosimendan Compared With Dobutamine on Renal Hemodynamics and Function in Chronic Heart Failure
Actual Study Start Date : April 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Levosimendan
Levosimendan administration is initiated with a loading dose of 12μg/kg given over 10 min followed by a continuous infusion of 0.1 μg/kg/min for 65 min.
Drug: Levosimendan
Other Name: Simdax

Active Comparator: Dobutamine
Dobutamine is given as a continuous infusion without a bolus dose. The infusion rate is started at 5.0 μg/kg/min for 10 minutes, and thereafter increased to 7,5 μg/kg/min for 65 min.
Drug: Dobutamine
Other Name: Dobutrex

Primary Outcome Measures :
  1. Change in renal blood flow [ Time Frame: 75 min minus baseline ]
    Para-aminohippuric acid (PAH) infusion clearance

  2. Change in glomerular filtration rate [ Time Frame: 75 min minus baseline ]
    Chrome-ethylenediaminetetraacetic acid (EDTA) infusion clearance

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written, signed and dated informed consent
  • Male and Female subjects ≥18 years of age
  • Chronic congestive heart failure scheduled for right sided cardiac catheterization
  • Left ventricular ejection fraction ≤ 40% determined by echocardiography
  • Elevation of N Terminal-proBNP ≥ 500 ng/L
  • Cardiorenal syndrome (30ml/min ≤ estimated GFR ≤ 80 ml/min (MDRD)

Exclusion Criteria:

  • Acute heart failure, untreated
  • Systolic blood pressure < 80 mmHg
  • Tachycardia above 100 bpm
  • Angina Canadian Cardiovascular Society (CCS) class III or higher
  • Aortic stenosis
  • Hypertrophic cardiomyopathy
  • Restrictive cardiomyopathy
  • The presence of kidney disease diagnosed before heart failure
  • Administration of radiographic contrast < 1 week
  • Radiographic contrast allergy
  • In the Investigator's opinion, the patient has a clinically significant disease that could be adversely affected by study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02133105

Layout table for location information
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Layout table for investigator information
Principal Investigator: Kristjan Karason, MD, PhD Sahlgrenska University Hospital, Department of Cardiology
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Göteborg University Identifier: NCT02133105    
Other Study ID Numbers: 2013-000986-36
2013-000986-36 ( EudraCT Number )
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Keywords provided by Göteborg University:
Heart failure
Renal failure
Inotropic drugs
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardio-Renal Syndrome
Heart Failure
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents