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Ivabradine in the Acute Management of Cardiogenic Shock

NCT07714746 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-20

No results posted yet for this study

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

Conditions

  • Cardiogenic Shock Post Myocardial Infarction

Interventions

DRUG

Ivabradine 5mg Tab

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

DRUG

Placebo Oral Tablet

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

Sponsors & Collaborators

  • National Institute of Cardiovascular Diseases, Pakistan

    lead OTHER

Principal Investigators

  • Asim Ali, MBBS · National Institute of Cardiovascular Diseases

  • Abdul Hakeem, MD FACC, FSCAI, FASE · National Institute of Cardiovascular Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07714746 on ClinicalTrials.gov