Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support (IVA-CS)

The Young Investigator Group of Cardiovascular Research

Status and phase: Enrolling; Phase 3

Conditions: Ischemic Heart Disease; Heart Failure; Cardiogenic Shock

Treatments: Drug: DOBUTamine Injectable Solution; Drug: Ivabradine 7.5Mg Tab

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05594342

YIG-10202201

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Decompensated heart failure with reduced ejection fraction (HFrEF) admitted for cardiogenic shock requiring inotropic support.

Exclusion criteria

• Decompensated heart failure with reduced ejection fraction (HFrEF) not requiring inotropic support.
• Patients with no oral intake
• Patients who refused to sign the consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Ivabradine+ dobutamine infusion

Experimental group

Description:

Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes.

Treatment:

Drug: Ivabradine 7.5Mg Tab

Drug: DOBUTamine Injectable Solution

Dobutamine infusion only

Active Comparator group

Description:

Patient will receive dobutamine infusion only for cardiogenic shock

Treatment:

Drug: DOBUTamine Injectable Solution