NCT07714746RecruitingPhase 3
Ivabradine in the Acute Management of Cardiogenic Shock
Ivabradine in the Acute Management of Cardiogenic Shock - IVASHOCK-a Double-blind Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 20 Apr 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Diseases
- Coronary artery disease
- NCT number
- NCT07714746
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 200
- From 20 Apr 2026 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Extensive comorbidities; Prior CVA, Malignancy, Pregnancy or Ongoing Participation in Other Trials
Other illness
- Complete Heart Block
- Heart rate of \< 100 bpm
- End stage Renal Disease
Age
- Age \> 75 years
Other
- CPR \> 12 mints
- Atrial fibrillation
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Cardiovascular Diseases Coordinator of this site? Confirm its status | Karachi | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.