EUCTR2008-001637-10-FIActive, not recruitingNot Applicable
Acute heart failure in acute coronary syndrome: Double blind comparison of levosimendan and placebo - LEVI´S
HUCH, Division of Cardiology0 sitesStarted: June 23, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
- •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
- •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
Investigators
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