Survival of patients with acute heart failure in need of intravenous inotropic support; a multicentre parallel- group, randomised, double- blind, double- dummy study of levosimendan versus dobutamine in patients with acute heart failure.

INTERVENTION: Trade Name: Simdax Product Name: levosimendan Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: levosimendan CAS Number: 141505‐33‐1 Current Sponsor code: (‐)‐OR‐1259 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intravenous use Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intravenous use Trade Name: Dobutrex Product Name: dobutamine Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: dobutamine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 12.5‐ Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intravenous use Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intravenous use CONDITION: Acutely decompensated heart failure PRIMARY OUTCOME: Main Objective: The primary objective of the study is to compare the efficacy of levosimendan to dobutamine on "All‐cause mortality" in the 180 days following randomisation. Primary end point(s): The primary objective is to compare the efficacy of levosimendan and dobutamine on "All‐cause mortality" in the 180 days following randomisation. ; ; Secondary Objective: To evaluate the efficacy of levosimendan compared to dobutamine on:; "Number of days alive out of hospital" during the 180 days following randomisation.; "All‐cause mortality" during the 31 days following randomisation. ; "Cardiovascular mortality" during the 180 days following randomisation.; "Global Assessment" at 24 hours following randomisation. ; Change in patient's evaluation of dyspnoea at 24 hours following randomisation. INCLUSION CRITERIA: 1. Written, signed, and dated informed consent. 2. Male and female patients over 18 years of age. Females of child bearing potential must have a negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal [(two years since last menstrual cycle] , surgically sterilised or have undergone a hysterectomy are considerd not to be of child bearing potential. 3. Hospitalised patients with acutely decompensated heart falure. 4. Left ventricular ejection fraction less than or equal to 30% as assessed using echocardiography, radionuclide ventriculography or contrast angiography within 12 months. 5. Clinical need for intravenous inotropic support as evidenced by insufficient response to intravenous diuretics and/or vasodilators (nitroglycerin, nitroprusside) and at least one of the following at screening: oligouria (mean urine output <30 ml/h for at least 6 hours) and not a results of hypovolemia. dyspnoea at rest or mechanic