Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Vilnius University128 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

128

Conditions

Patients With Cancer

Interventions

IvabradineDRUG

Ivabradine capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vilnius University Hospital Santaros klinikos

Vilnius, Lithuania

RECRUITING

Outcomes

Primary Outcomes

Change in left venticular dysfunction by global longitudinal strain (GLS).

Change in global longitudinal strain (GLS) at least by 3%.

Time frame: 1, 3 and 6 months

Secondary Outcomes

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.

Time frame: 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%.

Time frame: 1, 3 and 6 months

Central Contacts

Sigita Aidietiene, MD, PhD

CONTACT

37052365214 sigita.aidietiene@santa.lt

Egle Ciburiene, MD

CONTACT

37052365214 egle.ciburiene@santa.lt

Data from ClinicalTrials.gov

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