Ivabradine to Prevent Anthracycline-induced Cardiotoxicity
NCT ID: NCT04030546
Last Updated: 2019-12-18
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
128 participants
INTERVENTIONAL
2019-06-01
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ivabradine
Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until the last chemotherapy session
Ivabradine
Ivabradine capsule
Usual care
Patient will receive usual care
No interventions assigned to this group
Interventions
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Ivabradine
Ivabradine capsule
Eligibility Criteria
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Inclusion Criteria
* heart rate (HR) \> 70 times per minute;
* Written informed consent.
Exclusion Criteria
* HR\<70 times per minute;
* Incapability to complete informed consent;
* Severe valve disease;
* Left ventricular ejection fraction (LVEF)≤ 30 %;
* Other severe conditions;
* Poor echogenicity.
18 Years
80 Years
ALL
No
Sponsors
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Vilnius University
OTHER
Responsible Party
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Sigita Aidietiene
Assoc. Prof.
Principal Investigators
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Sigita Aidietiene, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vilnius University
Locations
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Vilnius University Hospital Santaros klinikos
Vilnius, , Lithuania
Countries
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Central Contacts
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Facility Contacts
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Egle Ciburiene, MD
Role: primary
Sigita Aidietiene, MD, PhD
Role: backup
Other Identifiers
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ICO
Identifier Type: -
Identifier Source: org_study_id