Rationale and design of RESILIENCE: A prospective randomized clinical trial evaluating remote ischaemic conditioning for the prevention of anthracycline cardiotoxicity

• Published in: European journal of heart failure 2024-10, Vol.26 (10), p.2213-2222
• Main Authors: García, Alberto, Kelm, Malte, Silva, María Gomes, Sánchez‐González, Javier, Sánchez, Pedro L., López‐Fernández, Teresa, Córdoba, Raul, Camus, Vincent, Smink, Jouke, Ferreira, Antonio, Kersten, Marie J., Bolaños, Natacha, Escalera, Noemi, Gómez‐Talavera, Sandra, Quesada, Antonio, Rosselló, Xavier, Ibanez, Borja, Martín, Alejandro, López, Javier, Peñarrubia, María Jesús, Vadillo, Irene Sánchez, Bastos, Mariana, Ubieto, Ana Jiménez, Barca, María Belén Navarro Eva González, Rodríguez, Guillermo, Berruezo, Antonio, Dacher, Jean‐Nicolas, Alonso, Arancha, Rivas, Jose Angel Hernández, Suarez, Julio García, Lebreton, Pierre, Rodríguez, Irene Sempere, Carretero, Jesús Molina, Vaquero, Ignacio Polo, Manchón, Ángel Franch, Delgado, Tamara Fernández, Fernández, Samuel Pérez, Menéndez, Manuel Desco, Álvarez, María López, Viyuela, Alba María Vega, Gambarte, Laura Pardo, Giles, Daniel Morillo, Ángeles Pérez Saenz, María, Palafox, Ester Macía, Dietrich, Sascha, Polzin, Amin, Voss, Fabian, Kamper, Peter Martin Hjørnet, Kjær, Sanne Nagstrup, Andersen, Katrine Frikke, Céu Trindade, Maria, Viegas, Diana, Harres, Vanessa, Ercan, Ece, Guzmán, Álvaro Navarro, Gonçalves, Fernando, Tilly, Hervé, Jardin, Fabrice, Stamatoullas, Aspasia, Zduniak, Alexandra, Lepretre, Stephane, Lenain, Pascal, Bouclet, Florian, Lanic, Helene, Lemasle, Emilie, Dubois, Sydney, Brehar, Oana, Richard, Doriane, Belilita, Ridha, Nederveen, Aart J, Eyiis, Esra, Heer, Koen, Agea, Esther, Baladrón, Carlos, Villar Moro, Candelas Perez, Gutiérrez, Norma Carmen Gutiérrez, Pacho, Leticia Vicente, Elorza, Begoña Navas, Martín, Javier Cucharero, Gil, Raquel, García, Mireia Bañuls, Peña, Alba Gutiérrez, Lopera, Sandra Gómez, Gotarredona, María Del Pilar Serrano, Pañella, Marina Huguet, Normant, Sébastien, Torre, Alejandra Segado, Mora, Mariana Tercero, Infante, María Stefania, Gascón, Isabel González, Novas, Carolina Muñoz, Ordoño, Raquel Fernandez, Almendral, Adrian Porcel, Ballester, Elena Flores, Jomarron, Isabel Gutierrez, Guerrero, Yolanda Martin, Gutierrez, Paola Villafuerte, Rubio, Montserrat Lopez, Picard, Angélique
• Format: Article
• Language: English
• Subjects: Adult; Anthracyclines; Anthracyclines - adverse effects; Biomarkers; Cardioprotection; Cardiotoxicity; Cardiotoxicity - etiology; Cardiotoxicity - prevention & control; Cardio‐oncology; Clinical Trials, Phase II as Topic; Double-Blind Method; Female; Heart failure; Humans; Ischaemic conditioning; Ischemic Preconditioning - methods; Ischemic Preconditioning, Myocardial - methods; Lymphoma - drug therapy; Magnetic resonance imaging; Magnetic Resonance Imaging, Cine - methods; Male; Middle Aged; Multicenter Studies as Topic; Prospective Studies; Randomized clinical trial; Randomized Controlled Trials as Topic; Strain; Stroke Volume; Ventricular Function, Left - drug effects; Ventricular Function, Left - physiology
• ISSN: 1388-9842; 1879-0844; 1879-0844
• DOI: 10.1002/ejhf.3395

Aims There is a lack of therapies able to prevent anthracycline cardiotoxicity (AC). Remote ischaemic conditioning (RIC) has shown beneficial effects in preclinical models of AC. Methods REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs (RESILIENCE) is a multinational, prospective, phase II, double‐blind, sham‐controlled, randomized clinical trial that evaluates the efficacy and safety of RIC in lymphoma patients receiving anthracyclines. Patients scheduled to undergo ≥5 chemotherapy cycles including anthracyclines and with ≥1 AC‐associated risk factors will be randomized to weekly RIC or sham throughout the chemotherapy period. Patients will undergo three multiparametric cardiac magnetic resonance (CMR) studies, at baseline, after the third cycle (intermediate CMR), and 2 months after the end of chemotherapy. Thereafter, patients will be followed up for clinical events over an anticipated median of ≥24 months. The primary endpoint is the absolute change from baseline in CMR‐based left ventricular ejection fraction (LVEF). The main secondary outcome is the incidence of AC events, defined as (1) a drop in CMR‐based LVEF of ≥10 absolute points, or (2) a drop in CMR‐based LVEF of ≥5 and