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.

Acute Heart Failure Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348504
• Other study ID #: 3001077
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2006
• Last updated: November 16, 2007
• Start date: March 2003
• Est. completion date: June 2005

Study information

• Verified date: November 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• levosimendan

• dobutamine

Locations

Country	Name	City	State
United States	Global Medical Information - Abbott	Abbott Park	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Orion Corporation, Orion Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality in the 180 days following randomization.
Secondary	All-cause mortality during the 31 days following randomization
Secondary	Mean change in plasma BNP concentration from baseline to 24 hours after the start of the study drug infusion
Secondary	Number of day alive and out of hospital (DAOH) during the 180 days following randomization
Secondary	Patient's evaluation of change in dyspnea at 24 hours following randomization
Secondary	Patient's evaluation of change in Global Assessment at 24 hours following randomization
Secondary	Cardiovascular mortality during the 180 days following randomization