Levosimendan Versus Dobutamine for Renal Function in Heart Failure

Cardiorenal Syndrome Clinical Trial

— ELDOR  

Official title:

Efficacy of Intravenous Levosimendan Compared With Dobutamine on Renal Hemodynamics and Function in Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133105
• Other study ID #: 2013-000986-36
• Secondary ID: 2013-000986-36
• Status: Completed
• Phase: Phase 3
• Start date: April 2014
• Est. completion date: May 2017

Study information

• Verified date: February 2020
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardio-Renal Syndrome
• Cardiorenal Syndrome
• Heart Failure

Intervention

Drug:
• Levosimendan

• Dobutamine

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Hillege HL, Girbes AR, de Kam PJ, Boomsma F, de Zeeuw D, Charlesworth A, Hampton JR, van Veldhuisen DJ. Renal function, neurohormonal activation, and survival in patients with chronic heart failure. Circulation. 2000 Jul 11;102(2):203-10. — View Citation

Hillege HL, Nitsch D, Pfeffer MA, Swedberg K, McMurray JJ, Yusuf S, Granger CB, Michelson EL, Ostergren J, Cornel JH, de Zeeuw D, Pocock S, van Veldhuisen DJ; Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) Investi — View Citation

Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2. — View Citation

Smith GL, Shlipak MG, Havranek EP, Masoudi FA, McClellan WM, Foody JM, Rathore SS, Krumholz HM. Race and renal impairment in heart failure: mortality in blacks versus whites. Circulation. 2005 Mar 15;111(10):1270-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in renal blood flow	Para-aminohippuric acid (PAH) infusion clearance	75 min minus baseline
Primary	Change in glomerular filtration rate	Chrome-ethylenediaminetetraacetic acid (EDTA) infusion clearance	75 min minus baseline
Secondary	Change in renal vascular resistance	Renal blood flow divided by the difference between renal arterial pressure and renal venous pressure	75 min minus baseline
Secondary	Change in central hemodynamics	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.	75 min minus baseline
Secondary	Change in renal oxygen consumption and oxygen extraction	Oxygen consumption: Renal blood flow multiplied by arterial-renal venous oxygen difference.; Oxygen extraction: Ratio of renal oxygen consumption to renal oxygen delivery	75 min minus baseline
Secondary	Change in filtration fraction	Ratio of glomerular filtration rate to renal plasma flow	75 min minus baseline