Clinical trial · Interventional
Cardioprotective Effects of Nebivolol Versus Placebo in Patients Undergoing Chemotherapy With Anthracyclines
Cardioprotective Effects of Nebivolol Versus Placebo in Patients Undergoing Chemotherapy With Anthracyclines (CONTROL 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)
As the cancer-related prognosis improves thanks to recent advances in cancer-targeted therapies, the prognostic burden of chemotherapy-related complications - including cardiotoxicity - is increasingly recognised. So far, the evidence supporting pharmacological preventive strategies in cardio-oncology has been inconsistent and conflicting, and there is a clear need for well-designed trials with novel interventions. In this study, by using cardiac magnetic resonance, the investigators want to assess if a commonly used beta-blocker with a unique pharmacological profile, i.e. nebivolol, can prevent cardiac dysfunction in patients with breast cancer or diffuse large B-cell lymphoma undergoing chemotherapy with anthracyclines.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiotoxicity | — | UNRESOLVED | — |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Left Ventricular Dysfunction | — | UNRESOLVED | — |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nebivolol | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nebivolol
- description
- nebivolol, capsule, 5 mg once daily, for 12 months
- interventionNames
- Drug: Nebivolol
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- placebo, capsule, once daily, for 12 months
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Left Ventricular Ejection Fraction reduction assessed by Cardiac Magnetic Resonance
- timeFrame
- from baseline to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Established histologic diagnosis of breast cancer or diffuse large B-cell lymphoma * Planned chemotherapy with anthracyclines * left ventricular ejection fraction ≥55% (assessed by echocardiography) * Ability to provide informed consent Exclusion Criteria: * Known intolerance/contraindications to betablocker therapy * History of coronary artery disease * History of cardiomyopathy * History of heart failure * Ongoing treatment with betablockers for other indications * Heart rate at baseline \<60 beats per minute * Arterial blood pressure at baseline \<100/60 mmHg * Contraindications to undergo cardiac magnetic resonance (e.g., non-compatible pacemakers or metallic prosthesis) * Pregnancy or lactation * Current participation to another study
References
Publications (1)
- DERIVEDCannata F, Stefanini G, Carlo-Stella C, Chiarito M, Figliozzi S, Novelli L, Lisi C, Bombace S, Panico C, Cosco F, Corrado F, Masci G, Mazza R, Ricci F, Monti L, Ferrante G, Santoro A, Francone M, da Costa BR, Juni P, Condorelli G. Nebivolol versus placebo in patients undergoing anthracyclines (CONTROL Trial): rationale and study design. J Cardiovasc Med (Hagerstown). 2023 Jul 1;24(7):469-474. doi: 10.2459/JCM.0000000000001491. PMID 37285278