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Ivabradine in the Acute Management of Cardiogenic Shock

RecruitingPhase 3Ages 18 Years - 75 YearsAllNational Institute of Cardiovascular Diseases, Pa…
NCT07714746 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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: Arteria

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📋 Eligibility rules (as published)
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 \<90 OR MAP \<60 OR \>30 mmHg drop from baseline AND drugs/device used to maintain BP above these targets 2. Cold, clammy extremities 3. Urine output \<30 mL/h 4. pulmonary congestion (either crackles, congestion in chest X-ray or B-lines in lung US) 5. 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 Exclusion Criteria: * Age \> 75 years * CPR \> 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
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What it tests

  • Ivabradine 5mg Tab
  • Placebo Oral Tablet
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Where

1 site
National institute of cardiovascular diseases
Karachi, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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