This is a randomized 1:1 blinded study that evaluate in acute left heart failure-cardiogenic shock patients if ivabradine treatment can reduce pulmonary wedge pressure, without inducing a significant or relevant reduction in cardiac output or increasing the risk of arterial hypotension and with the benefit of allowing a faster titration of heart failure drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
The target dose is 10 to 15 mg / day, administered orally in two doses
The study drug will be compared with the standard of Care treatment
Hospital Universitario Ramón y Cajal
Madrid, Spain
Changes from baseline in pulmonary wedge pressure and cardiac output after 24h-treatment with ivabradine or standard of care treatment.
Reduction of pulmonary wedge pressure from baseline in both treatment arms (ivabradine arm versus standard of care treatment measured by Swan Ganz balloon flotation catheter)
Time frame: 24 hours
Severe bradycardia
-Development of excessive bradycardia defined as heart rate (HR) \<50 beats per minute
Time frame: 24 hours
Arrhythmias
New-onset of ventricular arrhythmias or atrial fibrillation
Time frame: 24 hours
Hypotension
Hypotension, defined as systolic blood pressure \<90 mmHg
Time frame: 24 hours
Time to withdrawal of vasoactive drugs
-Time to catecholamine withdrawal in both treatment arms (days)
Time frame: 30 days
Time needing invasive mechanical ventilation
Mechanical (invasive) ventilation time after initiation of ivabradine/control treatment.
Time frame: 30 days
B-type natriuretic peptide (BNP)
Measured B-type natriuretic peptide (BNP) values at 30 days
Time frame: 30 days
Left ventricular ejection fraction
Change in left ventricle ejection fraction from baseline in both treatment arms (%)
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Time frame: 30 days
Cardiovascular mortality
Mortality due to cardiovascular causes
Time frame: 30 days
Total mortality
Mortality from any cause
Time frame: 30 days