Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Phase 3

• Conditions: Patients With Cancer
• Interventions: Drug: Ivabradine

• Registration Number: NCT04030546
• Lead Sponsor: Vilnius University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-06-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-24
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-18
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in left venticular dysfunction by global longitudinal strain (GLS).	1, 3 and 6 months	Change in global longitudinal strain (GLS) at least by 3%.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vilnius University Hospital Santaros klinikos; 🇱🇹 Vilnius, Lithuania