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

Orion Pharma0 sites700 target enrollmentSeptember 23, 2004

Overview

No summary available.

Registry

who.int

Start Date

September 23, 2004

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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:

•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.