Ivabradine in the Acute Management of Cardiogenic Shock

NCT07714746 | Recruiting Phase 3 DMC

• 1 other identifier: IRB-33/25
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.To determine whether ivabradine improves SCAI shock classification by at least one class from baseline within 72 hours compared to placebo
2. 2.To assess whether ivabradine facilitates earlier weaning from vasoactive and inotropic support compared to placebo

Conditions

Cardiogenic Shock Post Myocardial Infarction

Keywords

ivabradine; cardiogenic shock; SCAI Shock Stage Classification; Heart Rate Reduction; Randomized clinical trial; Shock Severity Improvement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ivabradine Plus Standard Care

EXPERIMENTAL

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

Matching Placebo Plus Standard Care

PLACEBO COMPARATOR

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

Interventions

Placebo Oral Tablet DRUG

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

Matching Placebo Plus Standard Care

Ivabradine 5mg Tab DRUG

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

Ivabradine Plus Standard Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

National institute of cardiovascular diseases

Karachi, Pakistan

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Asim Ali, MBBS

  National Institute of Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

• Abdul Hakeem, MD FACC, FSCAI, FASE

  National Institute of Cardiovascular Diseases

  STUDY CHAIR

Central Study Contacts

Umair Saleem, MBBS

CONTACT

+923363937264; umairsaleem1002@gmail.com

Asim Ali, MBBS

CONTACT

+92 301 3717252; dr.aasemali@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 20, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

PA (1)