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NCT07714746

Overview

NCT ID: NCT07714746
Lead Sponsor: National Institute of Cardiovascular Diseases, PakistanOTHER
Official Title: Ivabradine in the Acute Management of Cardiogenic Shock - IVASHOCK-a Double-blind Randomized Controlled Trial
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:

To determine whether ivabradine improves SCAI shock classification by at least one class from baseline within 72 hours compared to placebo

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 and Timeline

Status: Recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Apr 20, 2026Actual
Primary Completion Date: May 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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:

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

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

Study Plan

Study Type: Interventional
Phase: Phase 3
Enrollment: 200Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Umair Saleem, MBBSContact
umairsaleem1002@gmail.com+923363937264

Similar Studies

Participant Group/Arms

Ivabradine Plus Standard CareExperimental

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 CarePlacebo 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