Intravenous Vasodilator vs. Inotropic Therapy in Patients With Heart Failure

Exclusion Criteria

• •Clinical evidence of acute coronary syndrome (ACS) currently or within 30 days prior to enrollment. (Note that the diagnosis of ACS is a clinical diagnosis and that the sole presence of elevated troponin concentrations is not sufficient for a diagnosis of ACS).
• •Significant, uncorrected left ventricular outflow track obstruction, such us obstructive cardiomyopathy or severe aortic stenosis (i.e. aortic valve area \< 1.0 cm2 or mean gradient \> 40 mmHg on prior or current echocardiogram).
• •Severe mitral stenosis.
• •Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated.
• •Documented, prior to or at the time of the randomization, restrictive amyloid myocardiopathy or acute myocarditis or hypertrophic obstructive, restrictive or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
• •Complex congenital heart disease.
• •Significant arrhythmias, which include any of the following: sustained ventricular tachycardia; atrial fibrillation or atrial flutter with sustained heart rate \> 130 beats per minute.
• •Bradycardia with sustained ventricular rate \< 45 beats per minute.
• •Temperature \> 38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.
• •History of malignancy (other than localized basal cell carcinoma of the skin), treated or untreated or any terminal illness (other than heart failure) with a current life expectancy less than a year.
• •Major surgery or major neurologic event including cerebrovascular events, within 30 days prior to enrollment.
• •Need for mechanical circulatory support (MCS), including intra-aortic balloon pump, Extracorporeal Membrane Oxygenation (ECMO) or any ventricular assist device.
• •Need for mechanical ventilatory support (endotracheal intubation or mechanical ventilation).
• •Patient with chronic heart failure and inotropic-depended.
• •Current (within 2 hours prior to screening) treatment with any IV vasoactive therapies, including vasodilators, inotropic agents and vasopressors.
• •Patients with severe renal impairment defined as pre-randomization estimated Glomerular Filtration Rate (eGFR) \< 25 ml/min/1.73m2 calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equalization and/or those receiving current or planned dialysis or ultrafiltration.
• •Patients with acute kidney injury defined as an increase in serum creatinine 3 times of baseline, or reduction in urine output to \<0.3 mL/kg per hour for ≥12 hours, or anuria for ≥12 hours, or patients undergoing renal replacement therapy.
• •Patients with Child C cirrhosis or history of cirrhosis with evidence of portal hypertension such as varices.
• •Patients with acute liver failure and serum transaminase: aspartate transaminase (AST) and/or alanine transaminase (ALT) \> 3 times above the upper limit of normal.
• •Any major solid organ transplant recipient or planned/anticipated organ transplant within 1 year.
• •Patients with hematocrit \< 25%, or a history of blood transfusion within 14 days prior to screening, or active life-threatening gastrointestinal bleeding.
• •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test. .
• •History of hypersensitive to dobutamine or sodium nitroprusside.
• •Inability to follow instructions or comply with follow-up procedures.
• •Any other medical condition (s) that the investigator deems unsuitable for the study, including drug or alcohol use or psychiatric, behavioral or cognitive disorder.