Cardiogenic Shock Post Myocardial Infarction
Conditions
Keywords
ivabradine, cardiogenic shock, SCAI Shock Stage Classification, Heart Rate Reduction, Randomized clinical trial, Shock Severity Improvement
Brief 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
Interventions
Ivabradine 5mg oral BID for 3 days (6 tablets)
DRUGPlacebo Oral Tablet
Placebo tablets, with same color and texture, for 3 days in BID doses
Sponsors
National Institute of Cardiovascular Diseases, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hierarchical Composite Clinical Recovery at 72 Hours Assessed Using the Win Ratio | 72 hours | The primary outcome will be analyzed using a hierarchical win ratio. Participants will be compared sequentially as follows: (1) greater increase in total shock score from baseline to 72 hours; the score ranges from 0 to 12 and sums four 0-3 components: mean arterial pressure/vasoactive support, mixed venous oxygen saturation, urine output, and arterial lactate, with higher scores indicating better status; (2) less vasoactive/inotropic support at 72 hours, and if the number of agents is equal, the lower total dose; (3) lactate \<2 mmol/L; (4) mixed venous oxygen saturation ≥65%; (5) urine output ≥30 mL/hour; and (6) heart rate \<100 beats/min without symptomatic bradycardia, high-grade atrioventricular block, or new atrial fibrillation/flutter. If participants remain equal after all components, the comparison will be a tie. The effect will be reported as the win ratio (ivabradine wins/placebo wins). |
Countries
Pakistan
Contacts
CONTACTUmair Saleem, MBBS
CONTACTAsim Ali, MBBS
PRINCIPAL_INVESTIGATORAsim Ali, MBBS
National Institute of Cardiovascular Diseases
STUDY_CHAIRAbdul Hakeem, MD FACC, FSCAI, FASE
National Institute of Cardiovascular Diseases
Outcome results
None listed