Levosimendan Versus Dobutamine for Renal Function in Heart Failure

Phase 3

Completed

• Conditions: Cardiorenal Syndrome
• Interventions: Drug: Levosimendan; Drug: Dobutamine

• Registration Number: NCT02133105
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levosimendan	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.
Dobutamine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 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 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 filtration fraction	75 min minus baseline	Ratio of glomerular filtration rate to renal plasma flow

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden