Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support (IVA-CS)

October 20, 2022 updated by: Abdallah Almaghraby, The Young Investigator Group of Cardiovascular Research

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Alexandria, Egypt, 21521
        • Not yet recruiting
        • Andalusia Hospitals
        • Contact:
        • Sub-Investigator:
          • Abdallah Almaghraby, MSc
      • Alexandria, Egypt, 21521
        • Recruiting
        • Tiba Hospital
        • Contact:
        • Principal Investigator:
          • Abdelrahman Assal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ivabradine+ dobutamine infusion
Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes.
Drug: Ivabradine 7.5Mg Tab
Patients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes.
Other Names:
  • Ivabradine
Drug: DOBUTamine Injectable Solution
Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute
Other Names:
  • Dobutamine
Active Comparator: Dobutamine infusion only
Patient will receive dobutamine infusion only for cardiogenic shock
Drug: DOBUTamine Injectable Solution
Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute
Other Names:
  • Dobutamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 7 days
Time of weaning from dobutamine infusion
Time Frame: Up to 7 days
The time needed to completely wean dobutamine infusion calculated in hours
Up to 7 days
Duration of hospital stay
Time Frame: Up to 1 month
Total duration of hospital stay calculated in days
Up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)
Time Frame: Up to 1 month
Any ventricular arrhythmias will be documented
Up to 1 month
Supraventricular arrhythmia
Time Frame: Up to 1 month
Any supraventricular arrhythmias will be documented
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Young Investigator Group of Cardiovascular Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YIG-10202201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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