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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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levosimendan

Intervention Type DRUG

dobutamine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Robert J Padley, M.D.

Role: STUDY_DIRECTOR

Abbott

Locations

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Global Medical Information - Abbott

Abbott Park, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 19539144 (View on PubMed)

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.