ELDOR: Levosimendan Versus Dobutamine for Renal Function in Heart Failure

Sponsor

Göteborg University (Other)

Overall Status

Completed

CT.gov ID

NCT02133105

Collaborator

Sahlgrenska University Hospital, Sweden (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Apr 1, 2014

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

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 Names: 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 Names: Dobutrex

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 Names:

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 Names:

Dobutrex

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in renal vascular resistance [75 min minus baseline]
Renal blood flow divided by the difference between renal arterial pressure and renal venous pressure
Change in central hemodynamics [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 [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 [75 min minus baseline]
Ratio of glomerular filtration rate to renal plasma flow

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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