Ivabradine Effects in Cardiogenic Shock Requiring Inotropic Support

NCT05594342 | Unknown Phase 3 DMC

• 1 other identifier: YIG-10202201
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; Cardiogenic Shock; Ischemic Heart Disease

Keywords

Heart Failure; Cardiogenic shock; Ivabradine

Outcome Measures

Primary Outcomes (3)

• 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

• Time of weaning from dobutamine infusion

  The time needed to completely wean dobutamine infusion calculated in hours

  Up to 7 days

• Duration of hospital stay

  Total duration of hospital stay calculated in days

  Up to 1 month

Secondary Outcomes (2)

• Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation)

  Up to 1 month

• Supraventricular arrhythmia

  Up to 1 month

Study Arms (2)

Ivabradine+ dobutamine infusion

EXPERIMENTAL

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

Drug: Ivabradine 7.5Mg Tab; Drug: DOBUTamine Injectable Solution

Dobutamine infusion only

ACTIVE COMPARATOR

Patient will receive dobutamine infusion only for cardiogenic shock

Drug: DOBUTamine Injectable Solution

Interventions

Ivabradine 7.5Mg Tab DRUG

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

Also known as: Ivabradine

Ivabradine+ dobutamine infusion

DOBUTamine Injectable Solution DRUG

Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute

Also known as: Dobutamine

Dobutamine infusion only; Ivabradine+ dobutamine infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Decompensated heart failure with reduced ejection fraction (HFrEF) admitted for cardiogenic shock requiring inotropic support.

You may not qualify if:

• Decompensated heart failure with reduced ejection fraction (HFrEF) not requiring inotropic support.
• Patients with no oral intake
• Patients who refused to sign the consent

Sponsors & Collaborators

• The Young Investigator Group of Cardiovascular Research: lead

Study Sites (2)

Andalusia Hospitals

Alexandria, 21521, Egypt

NOT YET RECRUITING

Tiba Hospital

Alexandria, 21521, Egypt

RECRUITING

MeSH Terms

Conditions

Heart Failure; Shock, Cardiogenic; Myocardial Ischemia

Interventions

Ivabradine; Dobutamine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Infarction; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Abdallah Almaghraby, PhD

CONTACT

+201222851687; dr.maghraby@gmail.com

Mahmoud Abdelnabi, MD

CONTACT

+18065897577; mahmoud.hassan.abdelnabi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 26, 2022
• Study Start: July 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

EG (2)