Ivabradine for cardiogenic shock after a heart attack

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 randomized trial compares ivabradine to placebo in adults with STEMI complicated by cardiogenic shock. Participants receive oral ivabradine 5 mg every 12 hours for 3 days, with safety monitoring for rhythm and conduction issues and drug-related hypotension. Primary goals are to see if ivabradine improves the SCAI cardiogenic shock classification by at least one level within 72 hours and to determine if it enables earlier weaning from vasoactive and inotropic support. Secondary safety endpoints include sinus node dysfunction, atrial fibrillation or flutter, AV block, hypotension, and ventricular arrhythmias. Hemodynamic and metabolic parameters are repeatedly measured, including arterial pH, ScvO2, and lactate.

Why it matters

Who can join: the full rules

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

Where it's running

• National institute of cardiovascular diseases
  Karachi, Pakistan Recruiting

Study contacts

• Principal investigator: Asim Ali, MBBS — National Institute of Cardiovascular Diseases
• Study coordinator: Umair Saleem, MBBS
• Email: umairsaleem1002@gmail.com
• Phone: +923363937264

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rapid escalation from Impella CP to Impella 5.5 in cardiogenic shock after myocardial infarction

  This observational study tests whether quickly upgrading from an Impella CP to an Impella 5.5 in patients with heart failure after a heart attack improves outcomes.

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• Optimizing Impella 5.5 Outcomes With Advanced Data Science

  This study tests whether real-world data from Impella 5.5 patients with cardiogenic shock can help predict heart recovery and prevent complications, using advanced data science.

  Recruiting Medical University of Vienna · Vienna · NCT07619144

• Cardiogenic Shock Outcomes Registry (COR-SHOCK): how patients fare over time

  This observational registry tests how outcomes and management of cardiogenic shock have changed over the years in adults receiving routine care.

  Recruiting Hospital de Santa Cruz, Portugal · Carnaxide, Lisbon District · NCT07597291

• Outcomes in patients with mixed cardiogenic and vasoplegic shock

  This registry will try to describe outcomes and risk factors in adults admitted with cardiogenic shock who also have inappropriate vasodilation (mixed cardiogenic‑vasoplegic shock).

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens, Somme · NCT07354568

• Using beta-blockers for heart attack patients in intensive care

  This study is testing if the heart medication metoprolol can help heart attack patients in intensive care feel better and avoid worsening their condition.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT06967194

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.