Ivabradine in the Acute Management of Cardiogenic Shock
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Institute of Cardiovascular Diseases, Pakistan
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Age > 75 years
CPR > 12 mints
Atrial fibrillation
Complete Heart Block
Trial design
Design model
Parallel
Treatments tested in this trial
Ivabradine 5mg Tab
DrugIvabradine 5mg oral BID for 3 days (6 tablets)
Placebo Oral Tablet
DrugPlacebo tablets, with same color and texture, for 3 days in BID doses
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Ivabradine Plus Standard CareExperimental treatment 1 intervention
Group B: Matching Placebo Plus Standard CarePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hierarchical Composite Clinical Recovery at 72 Hours Assessed Using the Win Ratio
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).
Time frame
72 hoursSponsors and contacts
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Source ClinicalTrials.gov