Clinical trial NCT05594342: Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support
Official title: Effects of Adding Ivabradine in Patients With Cardiogenic Shock Requiring Inotropic Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Heart Failure
Cardiogenic Shock
Ischemic Heart Disease
Keywords: Heart Failure
Cardiogenic shock
Ivabradine
Lead sponsor: The Young Investigator Group of Cardiovascular Research
Sponsor class: NETWORK
First posted: 2022-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Heart rate reduction
timeFrame: Up to 7 days
measure: Time of weaning from dobutamine infusion
timeFrame: Up to 7 days
measure: Duration of hospital stay
timeFrame: Up to 1 month
Secondary outcomes:
measure: Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)
timeFrame: Up to 1 month
measure: Supraventricular arrhythmia
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Andalusia Hospitals
city: Alexandria
country: Egypt
facility: Tiba Hospital
Study officials:
References: