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.
Phase 1
- Conditions
- Cancers treated with anthracyclines: leukemias, limphomas, breast, stomach, uterine, ovarian, lung.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-000661-20-LT
- Lead Sponsor
- Vilnius University Hospital Santaros klinikos
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 150
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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy.<br> ;<br> Secondary Objective: 1. Incidence of anthracyclines induced cardiotoxicity and heart failure.<br> 2. Incidence of major cardiovascular outcomes.<br> ;<br> Primary end point(s): 1. Incidence of left venticle dysfunction by global longitudinal strain (GLS) reduction of = 3%.<br> 2. Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP.<br> 3. Incidence of left ventricular systolic and diastolic dysfunction.<br><br><br> ;Timepoint(s) of evaluation of this end point: After 1, 3, 6 and 7 months after start of chemotherapy with anthracyclines.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: At the end of the trial.;<br> Secondary end point(s): 1. Incidence of symptomatic heart failure.<br> 2. Incidence of adverse effects of ivabradine.<br> 3. Change in left ventricle and right ventricle dimensions by 2D and 3D echocardiography.<br> 4. Subgroup analysis by gender, age, type of cancer, cardiovascular risk factors.<br>