Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Study Overview
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Brief Summary
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The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy.

Detailed Description
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Cancer treatment with anthracyclines may cause heart damage and can lead to heart failure. There are drugs which may protect against cardiotoxic effects of anthracyclines (renin-angiotensin inhibitors and beta blockers), but they are not tolerated due to hypotension. Ivabradine is heart rate lowering drug without effect on blood pressure which was approved for treatment of angina pectoris and heart failure. The aim of this study is to investigate protective effects of ivabradine in cancer patients undergoing anthracycline-based chemotherapy. Ivabradine selectively inhibits If currents in the sinus node and prolongs the duration of spontaneous depolarization. That controls the heart's contractions and regulates the heart rate. Additionally, ivabradine might preserve myocardial function and contractility without effect on blood pressure. Ivabradine was approved for symptomatic treatment of chronic stable angina pectoris and chronic heart failure. The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy.

Official Title
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Ivabradine to Prevent Anthracycline-induced Cardiotoxicity: a Prospective Randomized Open Label Clinical Trial

Conditions
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Patients With Cancer

Intervention / Treatment
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* Drug: Ivabradine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cancer patients undergoing anthracyclines based chemotherapy; heart rate (HR) > 70 times per minute; Written informed consent. Exclusion Criteria: Contraindications for ivabradine administration; HR<70 times per minute; Incapability to complete informed consent; Severe valve disease; Left ventricular ejection fraction (LVEF)≤ 30 %; Other severe conditions; Poor echogenicity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ivabradine<br>Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until the last chemotherapy session | Drug: Ivabradine<br>* Ivabradine capsule<br>|
| No Intervention: Usual care<br>Patient will receive usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left venticular dysfunction by global longitudinal strain (GLS). | Change in global longitudinal strain (GLS) at least by 3%. | 1, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP | Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP. | 1, 3 and 6 months | 
| Incidence of left ventricular systolic and diastolic dysfunction by 2D and 3D echocardiography. | Incidence of left ventricular (LV) dysfunction defined as drop of LV ejection fraction by ≥ 10%. | 1, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthracycline chemotherapy, cardiotoxicity, heart failure