Clinical trial NCT04030546: Ivabradine to Prevent Anthracycline-induced Cardiotoxicity
Official title: Ivabradine to Prevent Anthracycline-induced Cardiotoxicity: a Prospective Randomized Open Label Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Patients With Cancer
Keywords: anthracycline chemotherapy
cardiotoxicity
heart failure
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in left venticular dysfunction by global longitudinal strain (GLS).
timeFrame: 1, 3 and 6 months
Secondary outcomes:
measure: Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP
timeFrame: 1, 3 and 6 months
measure: Incidence of left ventricular systolic and diastolic dysfunction by 2D and 3D echocardiography.
timeFrame: 1, 3 and 6 months
Other outcomes:
measure: Incidence of symptomatic heart failure.
timeFrame: 1, 3 and 6 months
measure: Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography.
timeFrame: 1, 3 and 6 months
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros klinikos
Study officials:
affiliation: Vilnius University
name: Sigita Aidietiene, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: