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

Göteborg University

Status and phase: Completed; Phase 3

Conditions: Cardiorenal Syndrome

Treatments: Drug: Dobutamine; Drug: Levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT02133105

2013-000986-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups

Levosimendan

Active Comparator group

Description:

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.

Treatment:

Drug: Levosimendan

Dobutamine

Active Comparator group

Description:

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.

Treatment:

Drug: Dobutamine