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.

Abbott

Status and phase

Completed

Phase 3

Conditions

Acute Heart Failure

Treatments

Drug: levosimendan

Drug: dobutamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00348504

3001077

Details and patient eligibility

About

The primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written, signed and dated informed consent
Male and female patients over 18 years of age. Females of childbearing 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 who have undergone a hysterectomy are considered not to be of childbearing potential
Hospitalised patients with acutely decompensated heart failure
Left ventricular ejection fraction less than or equal to 30 % as assessed using echocardiography, radionuclide ventriculography or contrast angiography within 12 months
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:
- oliguria (mean urine output < 30 ml/h for at least 6 hours) and not a result of hypovolemia
- dyspnoea at rest or mechanical ventilation for heart failure
- haemodynamic impairment in those patients with Swan-Ganz catheter inserted (PCWP ≥ 18 mmHg and/or Cardiac Index ≤ 2.2 l/min/m2)

Exclusion criteria

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
Weight ≥ 160 kg
Cardiac surgery within 30 days before screening
Stroke within 3 months before screening
Systolic blood pressure persistently less than 85 mmHg at screening or at baseline
Heart rate persistently 130 bpm or greater at screening or at baseline
Serum potassium less than 3.5 mmol/l at screening
Administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone, enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with dose of less than or equal than 2 mg/kg/min) during the current hospitalisation
Hypersensitivity to levosimendan or dobutamine or any of their excipients
A history of Torsades de Pointes
Severe renal insufficiency (serum creatinine > 450 mmol/l [5.0 mg/dl]) or on dialysis
Significant hepatic impairment at discretion of the investigator
Acute bleeding
Severe anemia (haemoglobin < 8 g/dl) at screening
Septicaemia or septic shock
Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer)
Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
Administration of levosimendan within 30 days prior to screening