Ivabradine in the Acute Management of Cardiogenic Shock - IVASHOCK-a Double-blind Randomized Controlled Trial
Objectives: 1. To determine whether ivabradine improves SCAI shock classification by at least one class from baseline within 72 hours compared to placebo 2. To assess whether ivabradine facilitates earlier weaning from vasoactive and inotropic support compared to placebo Safety Endpoints: Adverse events monitored include: sinus node dysfunction, new-onset atrial fibrillation or atrial flutter, atrioventricular block, drug-related hypotension, and ventricular arrhythmia. Participant Schedule: Participants will receive ivabradine or placebo orally every 12 hours for 3 days. Hemodynamic and metabolic assessments will include: Arterial pH, central venous oxygen saturation (ScvO2), and serum lactate - every 6 hours on Day 1, then every 8 hours on Days 2 and 3 Heart rate, mean arterial pressure (MAP), vasoactive/inotropic support dose, and urine output - measured on the same timeline
• Patients aged 18-75 years diagnosed with STEMI complicated by cardiogenic shock (CS) as defined by SCAI shock classification \> C:
• Signs of Hypoperfusion including:
⁃ SBP \<90 OR MAP \<60 OR \>30 mmHg drop from baseline AND drugs/device used to maintain BP above these targets
⁃ Cold, clammy extremities
⁃ Urine output \<30 mL/h
⁃ pulmonary congestion (either crackles, congestion in chest X-ray or B-lines in lung US)
⁃ Mixed venous oxygen saturation ≤ 65%
∙ Severe Left ventricular (LV) dysfunction or right ventricular (RV) infarction
‣ Heart rate (HR) ≥ 100 bpm (Sinus Rhythm) in whom beta-blocker therapy cannot be initiated, including: On inotropic or vasopressor support, Requiring an intra-aortic balloon pump (IABP), With Killip class III or IV, Requiring BiPAP or mechanical ventilation