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Recruiting
NCT07714746
Ivabradine in the Acute Management of Cardiogenic Shock
Conditions: Cardiogenic Shock Post Myocardial Infarction
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 200
Sponsor: National Institute of Cardiovascular Diseases, Pakistan
Location: National institute of cardiovascular diseases Karachi
Summary
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
Eligibility Criteria
Inclusion Criteria:
* Patients aged 18-75 years diagnosed with STEMI complicated by cardiogenic shock (CS) as defined by SCAI shock classification \> C:
Signs of Hypoperfusion including:
1. SBP \ 12 mints
* Atrial fibrillation
* Complete Heart Block
* Heart rate of \< 100 bpm
* End stage Renal Disease
* Extensive comorbidities; Prior CVA, Malignancy, Pregnancy or Ongoing Participation in Other Trials
Source: ClinicalTrials.gov (NCT07714746). StuddyBuddy aggregates publicly available trial information.