Status:
UNKNOWN
Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock
Lead Sponsor:
Hospital Universitario Ramon y Cajal
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Patients aged ≥ 18 years, with acute heart failure due to left ventricular systolic dysfunction (LVEF ≤ 40%) in sinus rhythm, baseline HR ≥ 90 bpm, with signs of low peripheral perfusion with indication for intravenous inotropic treatment (catecholamines: dobutamine , adrenaline, dopamine or noradrenaline) and admitted to the Cardiological Intensive Care Unit.
- Pharmacological treatment and stable hemodynamic situation in the 4 hours before inclusion.
- Pulmonary wedge pressure ≥ 18 mm Hg and systolic blood pressure \> 90 mm Hg.
- Patient's signature on the consent form.
Exclusion
- Previous treatment with ivabradine (\< 48 hours).
- Known hypersensitivity to ivabradine.
- Cardiac rhythm different from sinus rhythm.
- Unstable cardiac rhythm due to paroxysmal atrial fibrillation or atrial flutter, very frequent ventricular or supraventricular premature beats, ventricular tachycardia, 2nd or 3rd degree atrioventricular (AV) block.
- Severe chronic renal failure (estimated glomerular filtration rate ≤15 ml / min) or on chronic treatment with dialysis.
- QT interval higher than 450 ms.
- Sepsis as a probable mechanism of tachycardia and hypotension.
- Need for urgent cardiac surgery, planned within 72 hours of possible inclusion.
- Severe aortic stenosis or severe valvular disease that requires surgical correction.
- Patient must not have received an IV bolus of furosemide immediately before the baseline hemodynamic assessment.
- Severe hepatic insufficiency.
- Patient must not be participating in another clinical trial.
- Concomitant use of potent CYP3A4 inhibitors.
- Acute anemia or hypovolemia uncorrected.
- Pregnancy.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03437369
Start Date
May 1 2018
End Date
October 1 2019
Last Update
February 19 2018
Active Locations (1)
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1
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034