Clinical trial NCT02133105: Levosimendan Versus Dobutamine for Renal Function in Heart Failure
Official title: Efficacy of Intravenous Levosimendan Compared With Dobutamine on Renal Hemodynamics and Function in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiorenal Syndrome
Keywords: Heart failure
Renal failure
Inotropic drugs
Levosimendan
Dobutamine
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2014-05-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in renal blood flow
timeFrame: 75 min minus baseline
measure: Change in glomerular filtration rate
timeFrame: 75 min minus baseline
Secondary outcomes:
measure: Change in renal vascular resistance
timeFrame: 75 min minus baseline
measure: Change in central hemodynamics
timeFrame: 75 min minus baseline
measure: Change in renal oxygen consumption and oxygen extraction
timeFrame: 75 min minus baseline
measure: Change in filtration fraction
timeFrame: 75 min minus baseline
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital, Department of Cardiology
name: Kristjan Karason, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.