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

Primary Purpose

Heart Failure, Cardiogenic Shock, Ischemic Heart Disease

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Ivabradine 7.5Mg Tab
DOBUTamine Injectable Solution
Sponsored by
The Young Investigator Group of Cardiovascular Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Cardiogenic shock, Ivabradine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Andalusia Hospitals
  • Tiba HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ivabradine+ dobutamine infusion

Dobutamine infusion only

Arm Description

Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes.

Patient will receive dobutamine infusion only for cardiogenic shock

Outcomes

Primary Outcome Measures

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
Time of weaning from dobutamine infusion
The time needed to completely wean dobutamine infusion calculated in hours
Duration of hospital stay
Total duration of hospital stay calculated in days

Secondary Outcome Measures

Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)
Any ventricular arrhythmias will be documented
Supraventricular arrhythmia
Any supraventricular arrhythmias will be documented

Full Information

First Posted
October 4, 2022
Last Updated
October 20, 2022
Sponsor
The Young Investigator Group of Cardiovascular Research
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1. Study Identification

Unique Protocol Identification Number
NCT05594342
Brief Title
Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support
Acronym
IVA-CS
Official Title
Effects of Adding Ivabradine in Patients With Cardiogenic Shock Requiring Inotropic Support
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Young Investigator Group of Cardiovascular Research

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiogenic Shock, Ischemic Heart Disease
Keywords
Heart Failure, Cardiogenic shock, Ivabradine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine+ dobutamine infusion
Arm Type
Experimental
Arm Description
Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes.
Arm Title
Dobutamine infusion only
Arm Type
Active Comparator
Arm Description
Patient will receive dobutamine infusion only for cardiogenic shock
Intervention Type
Drug
Intervention Name(s)
Ivabradine 7.5Mg Tab
Other Intervention Name(s)
Ivabradine
Intervention Description
Patients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes.
Intervention Type
Drug
Intervention Name(s)
DOBUTamine Injectable Solution
Other Intervention Name(s)
Dobutamine
Intervention Description
Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute
Primary Outcome Measure Information:
Title
Heart rate reduction
Description
Amount of reduction of heart rate calculated by subtracting the heart rate at the time of weaning from the initial heart rate
Time Frame
Up to 7 days
Title
Time of weaning from dobutamine infusion
Description
The time needed to completely wean dobutamine infusion calculated in hours
Time Frame
Up to 7 days
Title
Duration of hospital stay
Description
Total duration of hospital stay calculated in days
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)
Description
Any ventricular arrhythmias will be documented
Time Frame
Up to 1 month
Title
Supraventricular arrhythmia
Description
Any supraventricular arrhythmias will be documented
Time Frame
Up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdallah Almaghraby, PhD
Phone
+201222851687
Email
dr.maghraby@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Abdelnabi, MD
Phone
+18065897577
Email
mahmoud.hassan.abdelnabi@gmail.com
Facility Information:
Facility Name
Andalusia Hospitals
City
Alexandria
ZIP/Postal Code
21521
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haitham Badran, MD
Email
Haithamcardiology@yahoo.com
First Name & Middle Initial & Last Name & Degree
Abdallah Almaghraby, MSc
Facility Name
Tiba Hospital
City
Alexandria
ZIP/Postal Code
21521
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdallah Almaghraby, PhD
Email
dr.maghraby@gmail.com
First Name & Middle Initial & Last Name & Degree
Abdelrahman Assal, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support

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