Single center, prospective, randomized, non-blinded research study comparing intravenous vasodilator infusion vs. inotropic infusion in patients admitted to the hospital or in the emergency room at Montefiore Medical Center presenting with the diagnosis of acute decompensated systolic heart failure with low cardiac output but no hypotensive.
The objective of the study is determine if the administration of diuretics with intravenous sodium nitroprusside (vasodilator therapy) in comparison to intravenous dobutamine (inotropic therapy) will lead to a reduction in the primary and secondary endpoints in patients with acute decompensated systolic heart failure with low cardiac output and no hypotensive.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Sodium nitroprusside is a medication used to lower blood pressure.
Dobutamine is a direct-acting inotropic agent whose primary activity results from stimulation of the ß receptors of the heart while producing comparatively mild chronotropic, hypertensive, arrhythmogenic, and vasodilative effects.
Furosemide is a prescription drug used to treat hypertension (high blood pressure) and edema. Learn about side effects, warnings, dosage, and more.
Montefiore Medical Center
The Bronx, New York, United States
Arrhythmia incidence
defined by the presence of ventricular arrhythmia (either ventricular tachycardia or ventricular fibrillation) or supraventricular arrhythmias (either recurrent or new onset of atrial fibrillation, atrial flutter or supraventricular tachycardia) with sustained heart rate ≥ 130 beats per minute
Time frame: within 72 hours after the initiation of the drug
Serum troponin T release
defined as measured serum cardiac troponin T (cTnT) with a value \> 0.10 ng/ml
Time frame: within 72 hours after the initiation of the drug
Hypotension incidence
defined as ≥ 2 consecutive blood pressure measurement with SBP \< 90 mmHg
Time frame: within 72 hours after the initiation of the drug
≥2 point improvement in the 5 point Likert dyspnea scale
Time frame: within 72 hours after the initiation of the drug involved in the study
≥ 30% improvement in the 100 point global patient assessment scale
Time frame: within 72 hours after the initiation of the drug involved in the study
Reduction in the Cardiac Care Unit length of stay
Length of stay (in hours) will be defined as the index discharge date and time minus the initiation of study drug date and time.
Time frame: Up to 30 days
Reduction in the hospitalization length of stay
Length of stay (in hours) will be defined as the index discharge date and time minus the initiation of study drug date and time.
Time frame: Up to 30 days
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Assessment of difference in restrictive filling pattern by echocardiogram
Time frame: from initiation of the of the drug involved in the study up to 72 hours.