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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Patients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes.
Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute
Andalusia Hospitals
Alexandria, Egypt
NOT_YET_RECRUITINGTiba Hospital
Alexandria, Egypt
RECRUITINGHeart rate reduction
Amount of reduction of heart rate calculated by subtracting the heart rate at the time of weaning from the initial heart rate
Time frame: Up to 7 days
Time of weaning from dobutamine infusion
The time needed to completely wean dobutamine infusion calculated in hours
Time frame: Up to 7 days
Duration of hospital stay
Total duration of hospital stay calculated in days
Time frame: Up to 1 month
Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)
Any ventricular arrhythmias will be documented
Time frame: Up to 1 month
Supraventricular arrhythmia
Any supraventricular arrhythmias will be documented
Time frame: Up to 1 month
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