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NCT Number: NCT07714746

Ivabradine in the Acute Management of Cardiogenic Shock

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

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Key information

Conditions

Cardiogenic Shock Post Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National institute of cardiovascular diseases

Karachi, Pakistan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivabradine 5mg Tab

Drug

Ivabradine 5mg oral BID for 3 days (6 tablets)

Placebo oral tablet

Drug

Placebo tablets, with same color and texture, for 3 days in BID doses

Primary outcomes

  1. Hierarchical Composite Clinical Recovery at 72 Hours Assessed Using the Win Ratio

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Asim Ali, MBBS

CONTACT

[email protected]

+92 301 3717252

Umair Saleem, MBBS

CONTACT

[email protected]

+923363937264

Sponsors and collaborators

Lead sponsor

National Institute of Cardiovascular Diseases, Pakistan

Other

Registry information

Official study title

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

Acronym: IVASHOCK

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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