Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support

Heart Failure Clinical Trial

— IVA-CS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05594342
• Other study ID #: YIG-10202201
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2022
• Source: The Young Investigator Group of Cardiovascular Research
• Contact: Abdallah Almaghraby, PhD
• Phone: +201222851687
• Email: dr.maghraby[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Ischemic Heart Disease
• Myocardial Ischemia
• Shock
• Shock, Cardiogenic

Intervention

Drug:
• Ivabradine 7.5Mg Tab
Patients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes.
• DOBUTamine Injectable Solution
Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute

Locations

Country	Name	City	State
Egypt	Andalusia Hospitals	Alexandria
Egypt	Tiba Hospital	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
The Young Investigator Group of Cardiovascular Research

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time of weaning from dobutamine infusion	The time needed to completely wean dobutamine infusion calculated in hours	Up to 7 days
Primary	Duration of hospital stay	Total duration of hospital stay calculated in days	Up to 1 month
Secondary	Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)	Any ventricular arrhythmias will be documented	Up to 1 month
Secondary	Supraventricular arrhythmia	Any supraventricular arrhythmias will be documented	Up to 1 month