Levosimendan Versus Dobutamine for Renal Function in Heart Failure

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Göteborg University
• Collaborator: Sahlgrenska University Hospital, Sweden
• Treatments: Dobutamine; Simendan

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