Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support
NCT ID: NCT05594342
Last Updated: 2022-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2022-07-01
2023-01-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ivabradine+ dobutamine infusion
Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes.
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
Dobutamine infusion only
Patient will receive dobutamine infusion only for cardiogenic shock
DOBUTamine Injectable Solution
Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with no oral intake
* Patients who refused to sign the consent
18 Years
ALL
No
Sponsors
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The Young Investigator Group of Cardiovascular Research
NETWORK
Responsible Party
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Abdallah Almaghraby
Associate Professor of Cardiology
Locations
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Andalusia Hospitals
Alexandria, , Egypt
Tiba Hospital
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YIG-10202201
Identifier Type: -
Identifier Source: org_study_id
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