search
Back to results

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

Primary Purpose

Cardiorenal Syndrome

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Levosimendan
Dobutamine
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiorenal Syndrome focused on measuring Heart failure, Renal failure, Inotropic drugs, Levosimendan, Dobutamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Levosimendan

Dobutamine

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in renal blood flow
Para-aminohippuric acid (PAH) infusion clearance
Change in glomerular filtration rate
Chrome-ethylenediaminetetraacetic acid (EDTA) infusion clearance

Secondary Outcome Measures

Change in renal vascular resistance
Renal blood flow divided by the difference between renal arterial pressure and renal venous pressure
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.
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
Change in filtration fraction
Ratio of glomerular filtration rate to renal plasma flow

Full Information

First Posted
May 5, 2014
Last Updated
February 24, 2020
Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden
search

1. Study Identification

Unique Protocol Identification Number
NCT02133105
Brief Title
Levosimendan Versus Dobutamine for Renal Function in Heart Failure
Acronym
ELDOR
Official Title
Efficacy of Intravenous Levosimendan Compared With Dobutamine on Renal Hemodynamics and Function in Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiorenal Syndrome
Keywords
Heart failure, Renal failure, Inotropic drugs, Levosimendan, Dobutamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levosimendan
Arm Type
Active Comparator
Arm 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.
Arm Title
Dobutamine
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Other Intervention Name(s)
Simdax
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Other Intervention Name(s)
Dobutrex
Primary Outcome Measure Information:
Title
Change in renal blood flow
Description
Para-aminohippuric acid (PAH) infusion clearance
Time Frame
75 min minus baseline
Title
Change in glomerular filtration rate
Description
Chrome-ethylenediaminetetraacetic acid (EDTA) infusion clearance
Time Frame
75 min minus baseline
Secondary Outcome Measure Information:
Title
Change in renal vascular resistance
Description
Renal blood flow divided by the difference between renal arterial pressure and renal venous pressure
Time Frame
75 min minus baseline
Title
Change in central hemodynamics
Description
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.
Time Frame
75 min minus baseline
Title
Change in renal oxygen consumption and oxygen extraction
Description
Oxygen consumption: Renal blood flow multiplied by arterial-renal venous oxygen difference. Oxygen extraction: Ratio of renal oxygen consumption to renal oxygen delivery
Time Frame
75 min minus baseline
Title
Change in filtration fraction
Description
Ratio of glomerular filtration rate to renal plasma flow
Time Frame
75 min minus baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristjan Karason, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28785469
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.
Results Reference
result
PubMed Identifier
16461840
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) Investigators. Renal function as a predictor of outcome in a broad spectrum of patients with heart failure. Circulation. 2006 Feb 7;113(5):671-8. doi: 10.1161/CIRCULATIONAHA.105.580506.
Results Reference
result
PubMed Identifier
15769768
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. doi: 10.1161/01.CIR.0000158131.78881.D5.
Results Reference
result
PubMed Identifier
10889132
Citation
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. doi: 10.1161/01.cir.102.2.203.
Results Reference
result
PubMed Identifier
30369310
Citation
Lannemyr L, Ricksten SE, Rundqvist B, Andersson B, Bartfay SE, Ljungman C, Dahlberg P, Bergh N, Hjalmarsson C, Gilljam T, Bollano E, Karason K. Differential Effects of Levosimendan and Dobutamine on Glomerular Filtration Rate in Patients With Heart Failure and Renal Impairment:A Randomized Double-Blind Controlled Trial. J Am Heart Assoc. 2018 Aug 21;7(16):e008455. doi: 10.1161/JAHA.117.008455.
Results Reference
derived

Learn more about this trial

Levosimendan Versus Dobutamine for Renal Function in Heart Failure

We'll reach out to this number within 24 hrs