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.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Cardiorenal Syndrome||Drug: Levosimendan Drug: Dobutamine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
Other Name: Dobutrex
- 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
- 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
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
|Sahlgrenska University Hospital|
|Gothenburg, Sweden, 41345|
|Principal Investigator:||Kristjan Karason, MD, PhD||Sahlgrenska University Hospital, Department of Cardiology|