Nebivolol versus placebo in patients undergoing anthracyclines (CONTROL Trial): rationale and study design.
J Cardiovasc Med (Hagerstown)
; 24(7): 469-474, 2023 07 01.
Article
em En
| MEDLINE
| ID: mdl-37285278
ABSTRACT
AIMS:
Anthracyclines are the chemotherapeutic agents most frequently associated with cardiotoxicity, while remaining widely used. Different neurohormonal blockers have been tested as a primary prevention strategy to prevent or attenuate the onset of cardiotoxicity, with mixed results. However, prior studies were often limited by a nonblinded design and an assessment of cardiac function based only on echocardiographic imaging. Moreover, on the basis of an improved mechanistic understanding of anthracycline cardiotoxicity mechanisms, new therapeutic strategies have been proposed. Among cardioprotective drugs, nebivolol might be able to prevent the cardiotoxic effects of anthracyclines, through its protective properties towards the myocardium, endothelium, and cardiac mitochondria. This study aims to evaluate the cardioprotective effects of the beta blocker nebivolol in a prospective, placebo-controlled, superiority randomized trial in patients with breast cancer or diffuse large B cell lymphoma (DLBCL) who have a normal cardiac function and will receive anthracyclines as part of their first-line chemotherapy programme.METHODS:
The CONTROL trial is a randomized, placebo-controlled, double-blinded, superiority trial. Patients with breast cancer or a DLBCL, with a normal cardiac function as assessed by echocardiography, scheduled for treatment with anthracyclines as part of their first-line chemotherapy programme will be randomized 1ââ1 to nebivolol 5âmg once daily (o.d.) or placebo. Patients will be examined with cardiological assessment, echocardiography and cardiac biomarkers at baseline, 1âmonth, 6âmonths and 12âmonths. A cardiac magnetic resonance (CMR) assessment will be performed at baseline and at 12âmonths. The primary end point is defined as left ventricular ejection fraction reduction assessed by CMR at 12âmonths of follow-up.CONCLUSION:
The CONTROL trial is designed to provide evidence to assess the cardioprotective role of nebivolol in patients undergoing chemotherapy with anthracyclines. CLINICAL TRIAL REGISTRATION The study is registered in the EudraCT registry (number 2017-004618-24) and in the ClinicalTrials.gov registry (identifier NCT05728632).
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
/
Antraciclinas
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article