Effects of Adding Ivabradine in Patients With Cardiogenic Shock Requiring Inotropic Support
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Duration of hospital stay
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ivabradine+ dobutamine infusion
Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes.
Intervention: Ivabradine 7.5Mg Tab (Drug)
Ivabradine+ dobutamine infusion
Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes.
Intervention: DOBUTamine Injectable Solution (Drug)
Dobutamine infusion only
Patient will receive dobutamine infusion only for cardiogenic shock
Intervention: DOBUTamine Injectable Solution (Drug)
Outcomes
Primary Outcomes
Duration of hospital stay
Time Frame: Up to 1 month
Total duration of hospital stay calculated in days
Heart rate reduction
Time Frame: Up to 7 days
Amount of reduction of heart rate calculated by subtracting the heart rate at the time of weaning from the initial heart rate
Time of weaning from dobutamine infusion
Time Frame: Up to 7 days
The time needed to completely wean dobutamine infusion calculated in hours
Secondary Outcomes
- Supraventricular arrhythmia(Up to 1 month)
- Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)(Up to 1 month)
Investigators
Abdallah Almaghraby
Associate Professor of Cardiology
The Young Investigator Group of Cardiovascular Research