Clinical trial · Interventional
Ivabradine to Prevent Anthracycline-induced Cardiotoxicity
Ivabradine to Prevent Anthracycline-induced Cardiotoxicity: a Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Anthracyclines are associated with cardiotoxic effects. Previous studies suggest that enalapril, and or carvedilol, protect against cardiovascular effects of these drugs. Ivabradine selectively reduces heart rate through inhibition of the cardiac pace maker IF channel, thus prolonging the duration of spontaneous depolarization in the sinus node. Additionally, ivabradine might preserve myocardial perfusion without negative inotropic effect and probably maintain cardiac contractility despite the reduction of heart rate. Ivabradine has been shown to improve outcome in patients with heart failure and angina. The aim of this study is to evaluate whether ivabradine might prevent anthracycline-induced cardiotoxicity.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiotoxicity | — | UNRESOLVED | — |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ivabradine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ivabradine
- description
- Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until one month after the last chemotherapy session.
- interventionNames
- Drug: Ivabradine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients will receive placebo just before anthracycline chemotherapy, one capsule per oral twice daily, until one month after the last chemotherapy session.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Ventricular function
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-year-old or older; * Cancer diagnosis; * Chemotherapy with anthracycline; * Written informed consent Exclusion Criteria: * Chronic Kidney Disease (Creatinine clearance inferior to 30mL/min/1.73m2) * Bradycardia (heart rate less than 60 beats per minute) * Atrial fibrilation; * Previous diagnosis of heart failure; * Pregnancy; * History of previous hypersensibility to the study drug; * Participating in another study protocol.
References
Publications (1)
- DERIVEDRizk SI, Costa IBSDS, Cruz CBBV, Pileggi B, de Almeida Andrade FT, Gonzalez TB, Bittar CS, Fukushima JT, Quintao VC, Osawa EA, Alves JBS, Fonseca SMR, Garcia DR, Pereira J, Buccheri V, Avila J, Kawahara LT, Barros CCS, Ikeoka LT, Nakada LN, Fellini M, Rocha VG, Rego EM, Hoff PMG, Filho RK, Landoni G, Hajjar LA. Randomized, Placebo-Controlled, Triple-Blind Clinical Trial of Ivabradine for the Prevention of Cardiac Dysfunction During Anthracycline-Based Cancer Therapy. J Am Heart Assoc. 2025 May 20;14(10):e039745. doi: 10.1161/JAHA.124.039745. Epub 2025 May 13. PMID 40357644