RecruitingPhase 3NCT07714746

Ivabradine in the Acute Management of Cardiogenic Shock

Ivabradine in the Acute Management of Cardiogenic Shock - IVASHOCK-a Double-blind Randomized Controlled Trial


Sponsor

National Institute of Cardiovascular Diseases, Pakistan

Enrollment

200 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ivabradine 5mg Tab and a drug called Placebo Oral Tablet for people with cardiogenic shock post myocardial infarction. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvabradine 5mg Tab

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


Locations(1)

National institute of cardiovascular diseases

Karachi, Pakistan

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NCT07714746


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