Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support
- Conditions
- Ischemic Heart DiseaseCardiogenic ShockHeart Failure
- Interventions
- Registration Number
- NCT05594342
- Lead Sponsor
- The Young Investigator Group of Cardiovascular Research
- 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 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Decompensated heart failure with reduced ejection fraction (HFrEF) admitted for cardiogenic shock requiring inotropic support.
- Decompensated heart failure with reduced ejection fraction (HFrEF) not requiring inotropic support.
- Patients with no oral intake
- Patients who refused to sign the consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dobutamine infusion only DOBUTamine Injectable Solution Patient will receive dobutamine infusion only for cardiogenic shock Ivabradine+ dobutamine infusion Ivabradine 7.5Mg Tab Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes. Ivabradine+ dobutamine infusion DOBUTamine Injectable Solution Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes.
- Primary Outcome Measures
Name Time Method Duration of hospital stay Up to 1 month Total duration of hospital stay calculated in days
Heart rate reduction 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 Up to 7 days The time needed to completely wean dobutamine infusion calculated in hours
- Secondary Outcome Measures
Name Time Method Supraventricular arrhythmia Up to 1 month Any supraventricular arrhythmias will be documented
Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation) Up to 1 month Any ventricular arrhythmias will be documented
Trial Locations
- Locations (2)
Andalusia Hospitals
🇪🇬Alexandria, Egypt
Tiba Hospital
🇪🇬Alexandria, Egypt