Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-22

Study Completion Date

2021-12-01

Brief Summary

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Anthracyclines are associated with cardiotoxic effects. Previous studies suggest that enalapril, and or carvedilol, protect against cardiovascular effects of these drugs.

Ivabradine selectively reduces heart rate through inhibition of the cardiac pace maker IF channel, thus prolonging the duration of spontaneous depolarization in the sinus node. Additionally, ivabradine might preserve myocardial perfusion without negative inotropic effect and probably maintain cardiac contractility despite the reduction of heart rate.

Ivabradine has been shown to improve outcome in patients with heart failure and angina. The aim of this study is to evaluate whether ivabradine might prevent anthracycline-induced cardiotoxicity.

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Detailed Description

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Conditions

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Neoplasms Heart Failure Cardiotoxicity Chemotherapy Effect Oncology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ivabradine

Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until one month after the last chemotherapy session.

Group Type ACTIVE_COMPARATOR

Ivabradine

Intervention Type DRUG

Ivabradine capsule

Placebo

Patients will receive placebo just before anthracycline chemotherapy, one capsule per oral twice daily, until one month after the last chemotherapy session.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral capsule.

Interventions

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Ivabradine

Ivabradine capsule

Intervention Type DRUG

Placebo

Placebo oral capsule.

Intervention Type DRUG

Other Intervention Names

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Placebo oral capsule

Eligibility Criteria

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Inclusion Criteria

* Age 18-year-old or older;
* Cancer diagnosis;
* Chemotherapy with anthracycline;
* Written informed consent

Exclusion Criteria

* Chronic Kidney Disease (Creatinine clearance inferior to 30mL/min/1.73m2)
* Bradycardia (heart rate less than 60 beats per minute)
* Atrial fibrilation;
* Previous diagnosis of heart failure;
* Pregnancy;
* History of previous hypersensibility to the study drug;
* Participating in another study protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No