Ivabradine in the Acute Management of Cardiogenic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ivabradine 5mg Tab, Placebo Oral Tablet.
- Who it may be relevant to
- Registry conditions: Cardiogenic Shock Post Myocardial Infarction. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ivabradine in the Acute Management of Cardiogenic Shock - IVASHOCK-a Double-blind Randomized Controlled Trial
Overview
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
- Drug Ivabradine 5mg Tab
Ivabradine 5mg oral BID for 3 days (6 tablets) - Drug Placebo Oral Tablet
Placebo tablets, with same color and texture, for 3 days in BID doses
Primary outcome measures
- Hierarchical Composite Clinical Recovery at 72 Hours Assessed Using the Win Ratio [Time frame: 72 hours]
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:
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- National institute of cardiovascular diseases — Karachi
Identifiers
NCT: NCT07714746 · IRB-33/25