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, but they are untolerated 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 to prevent anthracycline-induced cardiotoxicity: a prospective randomized open label clinical trial. - ICO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000661-20-LT

Enrollment

150

Registered

2019-04-04

Start date

2019-05-31

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancers treated with anthracyclines: leukemias, limphomas, breast, stomach, uterine, ovarian, lung.

Interventions

Trade Name: Ivabradine Anpharm 5 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivabradine 5 mg CAS Number: 148849-67-6 Other descriptive name: IVABRADINE HYDROCHLORIDE Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Chemotherapy with anthracyclines; • Age 18-80 years; • Heart rate = 70 times per minute; • Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: • Contraindications for ivabradine administration; • heart rate <70 times per minute; • Incapability to complete informed consent; • Severe valve disease; • Left ventricle ejection fraction = 30 proc.; • Poor echogenicity.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy. ;Secondary Objective: 1. Incidence of anthracyclines induced cardiotoxicity and heart failure. 2. Incidence of major cardiovascular outcomes.;Primary end point(s): 1. Incidence of left venticle dysfunction by global longitudinal strain (GLS) reduction of = 3%. 2. Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP. 3. Incidence of left ventricular systolic and diastolic dysfunction. ;Timepoint(s) of evaluation of this end point: After 1, 3, 6 and 7 months after start of chemotherapy with anthracyclines.	—

Measure

Time frame

Main Objective: The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy. ;Secondary Objective: 1. Incidence of anthracyclines induced cardiotoxicity and heart failure. 2. Incidence of major cardiovascular outcomes.;Primary end point(s): 1. Incidence of left venticle dysfunction by global longitudinal strain (GLS) reduction of = 3%. 2. Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP. 3. Incidence of left ventricular systolic and diastolic dysfunction. ;Timepoint(s) of evaluation of this end point: After 1, 3, 6 and 7 months after start of chemotherapy with anthracyclines.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Incidence of symptomatic heart failure. 2. Incidence of adverse effects of ivabradine. 3. Change in left ventricle and right ventricle dimensions by 2D and 3D echocardiography. 4. Subgroup analysis by gender, age, type of cancer, cardiovascular risk factors. ;Timepoint(s) of evaluation of this end point: At the end of the trial.	—

Countries

Lithuania

Contacts

Public ContactInvestigator

Vilnius University hospital Sanatros klinikos

egle.ciburiene@santa.lt+37068223328

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026