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

Autor: Moreno-Arciniegas A; Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain., García A; IIS-Fundación Jiménez Díaz, Madrid, Spain., Kelm M; Department of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, University Düsseldorf, Düsseldorf, Germany., D'Amore F; Aarhus University Hospital, Aarhus, Denmark., da Silva MG; Hematology, Instituto Português de Oncologia de Lisboa (IPO Lisboa), Lisbon, Portugal., Sánchez-González J; Philips Healthcare Iberia, Madrid, Spain., Sánchez PL; Hospital Universitario de Salamanca, Salamanca, Spain.; CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain., López-Fernández T; Cardiology Department, La Paz University Hospital, IdiPAZ Research Institute, Madrid, Spain., Córdoba R; IIS-Fundación Jiménez Díaz, Madrid, Spain., Asteggiano R; Faculty of Medicine, Insubria University, Varese, and Laboratorio Analisi e Ricerca Clinica, Turin, Italy., Camus V; Centre Henri Becquerel, Department of Hematology and INSERM U1245, Rouen, France., Smink J; Department of MR R&D-Clinical Science, Philips, Best, The Netherlands., Ferreira A; Hospital da Luz, Lisbon, Portugal., Kersten MJ; Department of Hematology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands., Bolaños N; Lymphoma Coalition Europe, Madrid, Spain., Escalera N; Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.; CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain., Pacella E; European Society of Cardiology, Nice, France., Gómez-Talavera S; Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.; IIS-Fundación Jiménez Díaz, Madrid, Spain.; CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain., Quesada A; Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain., Rosselló X; Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.; CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.; Hospital Universitari Son Espases-IDISBA, Universitat Illes Balears, Palma de Mallorca, Spain., Ibanez B; Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.; IIS-Fundación Jiménez Díaz, Madrid, Spain.; CIBER de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.
Jazyk: angličtina
Zdroj: European journal of heart failure [Eur J Heart Fail] 2024 Oct; Vol. 26 (10), pp. 2213-2222. Date of Electronic Publication: 2024 Aug 30.
DOI: 10.1002/ejhf.3395
Abstrakt: 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 <10 absolute points to a value <50%. Intermediate CMR will test the ability of T2 mapping to predict AC versus classical markers (left ventricular strain and cardiac injury biomarkers). A novel CMR sequence allowing ultrafast cine acquisition will be validated in this vulnerable population.
Conclusions: The RESILIENCE trial will test RIC (a novel non-invasive intervention to prevent AC) in a cohort of high-risk patients. The trial will also test candidate markers for their capacity to predict AC and will validate a novel CMR sequence reducing acquisition time in a vulnerable population.
(© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
Databáze: MEDLINE
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