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.

NCT00348504 | Completed Phase 3

• 1 other identifier: 3001077
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• All-cause mortality in the 180 days following randomization.

Secondary Outcomes (6)

• All-cause mortality during the 31 days following randomization

• Mean change in plasma BNP concentration from baseline to 24 hours after the start of the study drug infusion

• Number of day alive and out of hospital (DAOH) during the 180 days following randomization

• Patient's evaluation of change in dyspnea at 24 hours following randomization

• Patient's evaluation of change in Global Assessment at 24 hours following randomization

Interventions

levosimendan DRUG

dobutamine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (1)

Global Medical Information - Abbott

Abbott Park, Illinois, 60064, United States

Location

Related Publications (2)

• Cohen-Solal A, Logeart D, Huang B, Cai D, Nieminen MS, Mebazaa A. Lowered B-type natriuretic peptide in response to levosimendan or dobutamine treatment is associated with improved survival in patients with severe acutely decompensated heart failure. J Am Coll Cardiol. 2009 Jun 23;53(25):2343-8. doi: 10.1016/j.jacc.2009.02.058.

  PMID: 19539144 DERIVED

• Mebazaa A, Nieminen MS, Packer M, Cohen-Solal A, Kleber FX, Pocock SJ, Thakkar R, Padley RJ, Poder P, Kivikko M; SURVIVE Investigators. Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial. JAMA. 2007 May 2;297(17):1883-91. doi: 10.1001/jama.297.17.1883.

  PMID: 17473298 DERIVED

MeSH Terms

Interventions

Simendan; Dobutamine

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Catecholamines; Amines; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Robert J Padley, M.D.

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: March 1, 2003
• Study Completion: June 1, 2005
• Last Updated: November 20, 2007

Record last verified: 2007-11

Locations

US (1)