Ivabradine to prevent anthracycline-induced cardiotoxicity: a prospective randomized open label clinical trial.

INTERVENTION: 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 unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Trade Name: Ivabradine Anpharm 7,5 mg Product Name: Ivabradine Anpharm 7,5 mg Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Ivabradine Anpharm 7,5 mg CAS Number: 148849‐67‐6 Other descriptive name: IVABRADINE HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5‐ CONDITION: Cancers treated with anthracyclines: leukemias, limphomas, breast, stomach, uterine, ovarian, lung. Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: ; Main Objective: The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline‐based chemotherapy.; ; 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.; ; ; ; Secondary Objective: 1. Incidence of anthracyclines induced cardiotoxicity and heart failure.; 2. Incidence of major cardiovascular outcomes.; Timepoint(s) of evaluation of this end point: After 1, 3, 6 and 7 months after start of chemotherapy with anthracyclines. SECONDARY OUTCOME: ; 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. 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