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

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ClinicalTrials.gov Identifier: NCT02133105
Recruitment Status : Unknown
Verified February 2017 by Göteborg University.
Recruitment status was:  Enrolling by invitation
First Posted : May 7, 2014
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Study Start Date : April 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02133105


Locations
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Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Kristjan Karason, MD, PhD Sahlgrenska University Hospital, Department of Cardiology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02133105     History of Changes
Other Study ID Numbers: 2013-000986-36
2013-000986-36 ( EudraCT Number )
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Keywords provided by Göteborg University:
Heart failure
Renal failure
Inotropic drugs
Levosimendan
Dobutamine
Additional relevant MeSH terms:
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Cardio-Renal Syndrome
Heart Failure
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Dobutamine
Simendan
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors