Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Heart Failure, Cardiogenic Shock, Ischemic Heart Disease

Intervention / Treatment
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* Drug: Ivabradine 7.5Mg Tab
* Drug: DOBUTamine Injectable Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivabradine+ dobutamine infusion<br>Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes. | Drug: Ivabradine 7.5Mg Tab<br>* Patients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes.<br>* Other names: Ivabradine;Drug: DOBUTamine Injectable Solution<br>* Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute<br>* Other names: Dobutamine;|
| Active Comparator: Dobutamine infusion only<br>Patient will receive dobutamine infusion only for cardiogenic shock | Drug: DOBUTamine Injectable Solution<br>* Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute<br>* Other names: Dobutamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate reduction | Amount of reduction of heart rate calculated by subtracting the heart rate at the time of weaning from the initial heart rate | Up to 7 days | 
| Time of weaning from dobutamine infusion | The time needed to completely wean dobutamine infusion calculated in hours | Up to 7 days | 
| Duration of hospital stay | Total duration of hospital stay calculated in days | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation) | Any ventricular arrhythmias will be documented | Up to 1 month | 
| Supraventricular arrhythmia | Any supraventricular arrhythmias will be documented | Up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Cardiogenic shock, Ivabradine