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

• Register: EUCTR
• Last refreshed on: 22 April 2013
• Main ID: EUCTR2004-001225-16-AT
• Date of registration: 23/09/2004
• Prospective Registration: Yes
• Primary sponsor: Orion Pharma
• Public 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. - The SURVIVE study
• Scientific 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. - The SURVIVE study
• Date of first enrolment: 28/10/2004
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001225-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: yes Cross over: Other: yes Other trial design description: Double dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other:

Countries of recruitment

Austria

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Acutely decompensated heart failure

Intervention(s)

Trade Name: Simdax
Product Name: levosimendan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: levosimendan
CAS Number: 141505-33-1
Current Sponsor code: (-)-OR-1259
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intravenous use
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intravenous use

Trade Name: Dobutrex
Product Name: dobutamine
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: dobutamine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intravenous use
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Secondary Objective: To evaluate the efficacy of levosimendan compared to dobutamine on:
"Number of days alive out of hospital" during the 180 days following randomisation.
"All-cause mortality" during the 31 days following randomisation.
"Cardiovascular mortality" during the 180 days following randomisation.
"Global Assessment" at 24 hours following randomisation.
Change in patient's evaluation of dyspnoea at 24 hours following randomisation.

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.

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.

Secondary ID(s)

3001077