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. - The SURVIVE study

• Conditions: Acutely decompensated heart failure

• Registration Number: EUCTR2004-001225-16-AT
• Lead Sponsor: Orion Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-23
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. Written, signed, and dated informed consent.
2. Male and female patients over 18 years of age. Females of child bearing 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 have undergone a hysterectomy are considerd not to be of child bearing potential.
3. Hospitalised patients with acutely decompensated heart falure.
4. Left ventricular ejection fraction less than or equal to 30% as assessed using echocardiography, radionuclide ventriculography or contrast angiography within 12 months.
5. 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:
oligouria (mean urine output <30 ml/h for at least 6 hours) and not a results of hypovolemia.
dyspnoea at rest or mechanical ventilation for heart failure
haemodynamic impairment in those patients with Swan-Ganz catheter inserted (PCWP > or= 18 mm Hg and/or Cardiac Index < or = 2.2 l/min/m2.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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.
2. Weight > or = 160kg.
3. Cardiac surgery within 30 days before screening.
4. Stroke within 3 months before screening.
5. Systolic blood pressure persistently less than 85 mmHg at screening or baseline.
6. Heart rate persistently 130 bpm or greater at screening or baseline.
7. Serum potassium less than 3.5 mmol/l at screeing.
8. Administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with doses less than or equal than 2 microg/kg/min) during the current hospitalisation.
9. Hypersensitivity to levosimendan or dobutamine or any of their excipients.
10.A history of Torsades de Pointes.
11. Severe renal insufficiency (serum creatine > 450 micromol/l [5.0 mg/dl]) or on dialysis.
12. Significant hepatic impairment at discretion of the investigator.
13. Acute bleeding.
14. Severe anemia (haemoglobin < 8 g/dl) at screening.
15. Septicaemia or septic shock.
16. Other serious diseases limiting life expectancy considerably (e.g. end stage cancer).
17. Participation in a clinical trial with any experimental treatment within 30 days prior to sreening or previous participation in the present study.
18. Administration of levosimendan within 30 days prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to compare the efficacy of levosimendan to dobutamine on All-cause mortality in the 180 days following randomisation. ;Secondary Objective: To evaluate the efficacy of levosimendan compared to dobutamine on:<br>Number of days alive out of hospital during the 180 days following randomisation.<br>All-cause mortality during the 31 days following randomisation. <br>Cardiovascular mortality during the 180 days following randomisation.<br>Global Assessment at 24 hours following randomisation. <br>Change in patient's evaluation of dyspnoea at 24 hours following randomisation. ;Primary end point(s): The primary objective is to compare the efficacy of levosimendan and dobutamine on All-cause mortality in the 180 days following randomisation. <br><br>