Acute heart failure in acute coronary syndrome: Double blind comparison of levosimendan and placebo - LEVI´S

Conditions: Acute coronary syndrome treated with percutaneous coronary intervention (PCI)Patients suffering from acute heart failure after the procedure will be randomised to the study
MedDRA version: 9.1Level: LLTClassification code 10000803Term: Acute heart failure

Registration Number: EUCTR2008-001637-10-FI

Lead Sponsor: HUCH, Division of Cardiology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria

A. Acute coronary syndrome
- unstable angina, NSTEMI (non ST-elevation myocardial infarction), or STEMI (ST-elevation myocardial infarction) according to current guidelines.

and

B. symptoms and signs of heart failure:
1. hypoxia and dyspnea at rest due to decompensated CHFo
2. increased filling pressure (pulmonary artery wedge pressure (PCWP) > 20 mmHg) by Swan-gantz catheter or by echocardiographic estimation.

C. Written informed consent by patient or a close relative

D. Age >18 years

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

Exclusion criteria

•Pregnancy
•Cardiogenic shock
•Systolic arterial pressure below 100 mmHg despite of adequate fluid balance
•Heart rate > 120 bpm
•Sustained ventricular tachycardia not related to early perfusion
•Use of intravenous ß-adrenergic agonists during admission within 24 hours before screening , and intravenous PDE inhibitors (e.g., milrinone, amrinone) within 2 days.
•Vasopressor treatment
•Pneumonia or sepsis
•ARDS; hypoxemia due to severe COPD
•Heart failure due to restrictive or hypertrophic cardiomyopathy or to uncorrected stenotic valvular disease
•Planned surgery
•Known hypersensitivity to study medication
•Known history of Torsades de pointes
•hypo- or hyperkalemia
•significant renal or hepatic failure
•intra aortic balloon pump or left ventricular assist device

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The hypothesis of the study is that Levosimendan infusion added on the top of standard therapy facilitates the clinical symptoms and hemodynamic parameters in heart failure due to acute myocardial infarction. The primary end point is invasively measured decrease in pulmary artery capillary wedge pressure (PCWP) during 48 hours. ;Secondary Objective: Secondary objective is to study the safety of Levosimendan in acute coronary syndrome patients;Primary end point(s): Area under the curve for the decrease in invasively measured pulmonary artery capillary pressure (PCWP) during 48 h after beginning of study medication (levosimendan or placebo) treatment. <br>

Secondary Outcome Measures