Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Vilnius University

Status and phase: Unknown; Phase 3

Conditions: Patients With Cancer

Treatments: Drug: Ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT04030546

ICO

Details and patient eligibility

About

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

Full description

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Ivabradine

Active Comparator group

Description:

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

Treatment:

Drug: Ivabradine

Usual care

No Intervention group

Description:

Patient will receive usual care