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Ivabradine in the Acute Management of Cardiogenic Shock

Study acronym: IVASHOCK
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Brief Summary: The IVASHOCK trial investigates whether ivabradine can achieve at least one-class improvement in SCAI cardiogenic shock classification compared to placebo, and evaluates its safety profile in patients with cardiogenic shock (CS). Primary 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
Trial Details
NCT Number NCT07714746
Lead Sponsor National Institute of Cardiovascular Diseases, Pakistan
Conditions
(from sponsor)
Cardiogenic Shock Post Myocardial Infarction
Related terms Shock, Cardiogenic
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov