Ivabradine in the Acute Management of Cardiogenic Shock (IVASHOCK)

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

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock Post Myocardial Infarction
• Intervention / Treatment: Drug: Ivabradine 5mg Tab; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Umair Saleem, MBBS; Phone Number: +923363937264; Email: umairsaleem1002@gmail.com
• Study Contact Backup: Name: Asim Ali, MBBS; Phone Number: +92 301 3717252; Email: dr.aasemali@gmail.com

Study Locations

• Pakistan
  • Karachi, Pakistan
    • Recruiting
    • National institute of cardiovascular diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ivabradine Plus Standard Care; Participants will receive standard treatment for STEMI complicated by cardiogenic shock, including revascularization, guideline-directed medical therapy as clinically appropriate, standardized vasopressor and inotropic support, and mechanical circulatory support when indicated. Participants will receive ivabradine 5 mg orally twice daily for up to 3 days, with a maximum of six doses. Study treatment will be discontinued if the heart rate decreases to <72 bpm or a beta-blocker is initiated.	Drug: Ivabradine 5mg Tab; Ivabradine 5mg oral BID for 3 days (6 tablets)
Placebo Comparator: Matching Placebo Plus Standard Care; Participants will receive the same standard treatment for STEMI complicated by cardiogenic shock, including revascularization, guideline-directed medical therapy as clinically appropriate, standardized vasopressor and inotropic support, and mechanical circulatory support when indicated. Participants will receive a matching placebo tablet orally twice daily for up to 3 days, with a maximum of six doses. Study treatment will be discontinued if the heart rate decreases to <72 bpm or a beta-blocker is initiated.	Drug: Placebo Oral Tablet; Placebo tablets, with same color and texture, for 3 days in BID doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	72 hours

Collaborators and Investigators

• Sponsor: National Institute of Cardiovascular Diseases, Pakistan
• Investigators: Principal Investigator: Asim Ali, MBBS, National institute of cardiovascular diseases; Study Chair: Abdul Hakeem, MD FACC, FSCAI, FASE, National institute of cardiovascular diseases

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized clinical trial; cardiogenic shock; ivabradine; SCAI Shock Stage Classification; Heart Rate Reduction; Shock Severity Improvement
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Shock, Cardiogenic; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Ivabradine
• Other Study ID Numbers: IRB-33/25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No