Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Ramon y Cajal

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.