Levosimendan Versus Dobutamine for Renal Function in Heart Failure

Condition(s) targeted: Cardiorenal Syndrome

Intervention: Levosimendan (Drug); Dobutamine (Drug)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: Göteborg University

Official(s) and/or principal investigator(s):
Kristjan Karason, MD, PhD, Principal Investigator, Affiliation: Sahlgrenska University Hospital, Department of Cardiology

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change in renal blood flow

Change in glomerular filtration rate

Secondary outcome:

Change in renal vascular resistance

Change in central hemodynamics

Change in renal oxygen consumption and oxygen extraction

Change in filtration fraction

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Sahlgrenska University Hospital, Gothenburg 41345, Sweden

Starting date: April 2014
Last updated: May 28, 2015