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The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivabradine | Active Comparator | Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until the last chemotherapy session |
|
| Usual care | No Intervention | Patient will receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine | Drug | Ivabradine capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in left venticular dysfunction by global longitudinal strain (GLS). | Change in global longitudinal strain (GLS) at least by 3%. | 1, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP | Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP. | 1, 3 and 6 months |
| Incidence of left ventricular systolic and diastolic dysfunction by 2D and 3D echocardiography. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic heart failure. | Incidence of symptomatic heart failure. | 1, 3 and 6 months |
| Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography. | Changes in left ventricular and right ventricular dimensions by 2D and 3D echocardiography. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sigita Aidietiene, MD, PhD | Contact | 37052365214 | sigita.aidietiene@santa.lt | |
| Egle Ciburiene, MD | Contact | 37052365214 | egle.ciburiene@santa.lt |
| Name | Affiliation | Role |
|---|---|---|
| Sigita Aidietiene, MD, PhD | Vilnius University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vilnius University Hospital Santaros klinikos | Recruiting | Vilnius | 08661 | Lithuania |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Parallel Assignment
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Incidence of left ventricular (LV) dysfunction defined as drop of LV ejection fraction by ≥ 10%. |
| 1, 3 and 6 months |
| 1, 3 and 6 months |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |