Cardiorenal Syndrome
Conditions
Keywords
Heart failure, Renal failure, Inotropic drugs, Levosimendan, Dobutamine
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.
Interventions
DRUGLevosimendan
DRUGDobutamine
Sponsors
Sahlgrenska University Hospital
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in renal blood flow | 75 min minus baseline | Para-aminohippuric acid (PAH) infusion clearance |
| Change in glomerular filtration rate | 75 min minus baseline | Chrome-ethylenediaminetetraacetic acid (EDTA) infusion clearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in renal vascular resistance | 75 min minus baseline | Renal blood flow divided by the difference between renal arterial pressure and renal venous pressure |
| Change in central hemodynamics | 75 min minus baseline | 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 | 75 min minus baseline | 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 | 75 min minus baseline | Ratio of glomerular filtration rate to renal plasma flow |
Countries
Sweden
Outcome results
None listed