NCT05594342

Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support

Effects of Adding Ivabradine in Patients With Cardiogenic Shock Requiring Inotropic Support

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The Young Investigator Group of Cardiovascular Research · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1 This study aimed to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support.

Detailed description

Background and study rationale: Ivabradine is a Heart Rate (HR) lowering agent which acts by inhibiting the If current in the sinoatrial node. It is currently indicated in patients with chronic heart failure with reduced ejection fraction (HFrEF). Dobutamine is an inotropic drug used in cardiogenic shock patients and it is associated with an increase in HR and incidence of cardiac arrhythmias.2 However, studies have suggested that increased heart rate may be deleterious in decompensated HFrEF due to an inverted Bowditch-Treppe response. Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1, 2 Aim of the work: * This study aims to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support. * Design: Randomized open-label interventional clinical trial. Methods and patients: * Study Type: Interventional (Clinical Trial) * Estimated Enrollment: 200 participants * Allocation: Randomized * Perspective: Prospective Study * Intervention Model: Two Group Assignment * Masking: None (Open Label) * Primary purpose: Treatment * Official title: Ivabradine effects in cardiogenic shock requiring inotropic support (IVA-CS) * Start Date: 01 August 2022 * Estimated Primary Completion Date: 01 January 2023

Conditions

• Heart Failure
• Cardiogenic Shock
• Ischemic Heart Disease

Interventions

Type	Name	Description
DRUG	Ivabradine 7.5Mg Tab	Patients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes.
DRUG	DOBUTamine Injectable Solution	Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2022-10-26
• Last updated: 2022-10-26

Locations

2 sites across 1 country: Egypt