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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.

Information source: Abbott
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Heart Failure

Intervention: levosimendan (Drug); dobutamine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Robert J Padley, M.D., Study Director, Affiliation: Abbott

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.

Clinical Details

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.

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

Primary outcome: All-cause mortality in the 180 days following randomization.

Secondary outcome:

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

Cardiovascular mortality during the 180 days following randomization

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Global Medical Information - Abbott, Abbott Park, Illinois 60064, United States
Additional Information

Starting date: March 2003
Last updated: November 16, 2007

Page last updated: August 20, 2015

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