Patients With Cancer
Conditions
Keywords
anthracycline chemotherapy, cardiotoxicity, heart failure
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.
Interventions
DRUGIvabradine
Ivabradine capsule
Sponsors
Vilnius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of symptomatic heart failure. | 1, 3 and 6 months | Incidence of symptomatic heart failure. |
| Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography. | 1, 3 and 6 months | Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography. |
Countries
Lithuania
Contacts
Primary ContactSigita Aidietiene, MD, PhD
Backup ContactEgle Ciburiene, MD
Outcome results
None listed