Acutely decompensated heart failure
Conditions
Interventions
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
Con
Sponsors
Orion Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
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 or= 18 mm Hg and/or Cardiac Index =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy. 2. Weight > or = 160kg. 3. Cardiac surgery within 30 days before screening. 4. Stroke within 3 months before screening. 5. Systolic blood pressure persistently less than 85 mmHg at screening or baseline. 6. Heart rate persistently 130 bpm or greater at screening or baseline. 7. Serum potassium less than 3.5 mmol/l at screeing. 8. Administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with doses less than or equal than 2 microg/kg/min) during the current hospitalisation. 9. Hypersensitivity to levosimendan or dobutamine or any of their excipients. 10.A history of Torsades de Pointes. 11. Severe renal insufficiency (serum creatine > 450 micromol/l [5.0 mg/dl]) or on dialysis. 12. Significant hepatic impairment at discretion of the investigator. 13. Acute bleeding. 14. Severe anemia (haemoglobin < 8 g/dl) at screening. 15. Septicaemia or septic shock. 16. Other serious diseases limiting life expectancy considerably (e.g. end stage cancer). 17. Participation in a clinical trial with any experimental treatment within 30 days prior to sreening or previous participation in the present study. 18. Administration of levosimendan within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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. ;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. | — |
Countries
Austria
Outcome results
None listed