NCT07714746 Ivabradine in the Acute Management of Cardiogenic Shock
| NCT ID | NCT07714746 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | National Institute of Cardiovascular Diseases, Pakistan |
| Condition | Cardiogenic Shock Post Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2026-04-20 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Asim Ali, MBBS
PRINCIPAL INVESTIGATOR
National Institute of Cardiovascular Diseases
Frequently Asked Questions
Who can join the NCT07714746 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Cardiogenic Shock Post Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07714746 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT07714746 currently recruiting?
Yes, NCT07714746 is actively recruiting participants. Contact the research team at umairsaleem1002@gmail.com for enrollment information.
Where is the NCT07714746 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT07714746 clinical trial?
NCT07714746 is sponsored by National Institute of Cardiovascular Diseases, Pakistan. The principal investigator is Asim Ali, MBBS at National Institute of Cardiovascular Diseases. The trial plans to enroll 200 participants.