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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.
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:
Methods and patients:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivabradine+ dobutamine infusion | Experimental | Patients will receive ivabradine 7.5 mg twice daily via oral route after starting dobutamine infusion by 30 minutes. |
|
| Dobutamine infusion only | Active Comparator | Patient will receive dobutamine infusion only for cardiogenic shock |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine 7.5Mg Tab | Drug | Patients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation) | Any ventricular arrhythmias will be documented | Up to 1 month |
| Supraventricular arrhythmia | Any supraventricular arrhythmias will be documented |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdallah Almaghraby, PhD | Contact | +201222851687 | dr.maghraby@gmail.com | |
| Mahmoud Abdelnabi, MD | Contact | +18065897577 | mahmoud.hassan.abdelnabi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andalusia Hospitals | Not yet recruiting | Alexandria | 21521 | Egypt |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D012770 | Shock, Cardiogenic |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| D004280 | Dobutamine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| DOBUTamine Injectable Solution | Drug | Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute |
|
|
| Up to 1 month |
| Tiba Hospital | Recruiting | Alexandria | 21521 | Egypt |
|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |