Effects of carvedilol on the prevention of cardiotoxicity induced by anthracyclines: Design and rationale of the CARDIOTOX trial.
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Costa Isabela Bispo Santos da Silva, Furtado Remo H M, Drager Luciano F, de Barros E Silva Pedro Gabriel Melo, Melo Marcelo Dantas Tavares de, Araruna Paula, Bacchiega Bruno C, Cauduro Sanderson, Walter Edilson, Fialho Guilherme Loureiro, Silvestre Odilson, Damiani Lucas P, Barbosa Lilian M, Luz Mariane Nascimento, Silva Ana Cecilia Alcantara, de Mattos Renata Rodrigues, Saretta Roberta, Rehder Marilia Harumi H S, Hajjar Ludhmila Abrahao, Lopes-Fernandez Teresa, Dent Susan, Gibson C Michael, Lopes Renato D, Kalil Filho Roberto, CARDIOTOX Investigators
Аннотация
DESIGN: CARDIOTOX is a double-blind, placebo controlled randomized clinical trial that plan to enroll 1,018 patients across 25 study sites in Brazil. Patients with active cancer scheduled to undergo an anthracycline-based chemotherapy regimen are eligible. Patients with prior HF or cardiomyopathy are excluded. Patients are randomized in 1:1 ratio to carvedilol (starting dose 6.25mg BID up titrated to 25mg BID or maximum tolerated dose) or placebo, stratified by site and use of renin-angiotensin blockers at baseline. Study drug is administered through the duration of chemotherapy and up to 30 days after the last dose of anthracycline. Patients are scheduled to undergo echocardiographic evaluations at baseline and at 3, 6, and 12 months. The study primary endpoint is the composite of new left ventricle ejection fraction (LVEF) reduction by at least 10% leading to an LVEF <50%, cardiovascular death, myocardial infarction, urgent care visit or hospitalization for heart failure, or clinically significant arrhythmias at 12 months. Echocardiographic images will be analyzed by a central core lab, clinical outcomes will be adjudicated, and safety endpoints include serious adverse events and adverse events of special interest (symptomatic bradycardia, hypotension, syncope and bronchospasm).
SUMMARY: The CARDIOTOX trial is the largest trial to date analyzing the potential role of beta-blockers as prophylactic therapy to prevent cardiotoxicity induced by anthracyclines.
TRIAL REGISTRATION: Effects of Carvedilol on Cardiotoxicity in Cancer Patients Submitted to Anthracycline Therapy (CardioTox).
CLINICALTRIALS: gov ID NCT04939883. https://clinicaltrials.gov/study/NCT04939883.