The RESILIENCE project develop a novel healthcare intervention (Remote Ischemic Conditioning, RIC) aimed at reducing the prevalence of chronic heart failure in cancer survivors.
Remote ischemic conditioning (RIC) is a phenomenon by which brief, reversible episodes of occlusion and re-occlusion in one organ (e.g. an arm) render remote organs resistant to injury.
Cardiac magnetic resonance (CMR) it is a technique without radiation, which is considered the gold-standard for the evaluation of cardiac anatomy, function and even tissue composition. The RESILIENCE trial will use CMR as the main outcome measure methodology, and patients enrolled in the trial will undergo 3 scans across the duration of the study.
Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic Conditioning (RIC) in Lymphoma patients receiving anthracyclines. Patients scheduled to undergo ≥5 chemotherapy cycles will be eligible.
RESILIENCE is a multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of weekly remote ischemic conditioning in Lymphoma patients receiving anthracyclines.
Patients scheduled to undergo several chemotherapy cycles will be eligible. Patients fulfilling all inclusion and no exclusion criteria will be enrolled and undergo three Cardiac Magnetic Baseline studies before, during and after chemotherapy. Patients with confirmed LVEF >40% by CMR will be randomized 1:1 to remote ischemic conditioning vs simulated remote ischemic conditioning (Sham). Patients will be followed-up for clinical events. The median follow-up estimation for clinical endpoints is 24 months.
Key secondary endpoints:
Rate of anthracycline-induced cardiotoxicity events, rate of arrhythmias, time to all cause death or heart failure hospitalization.
Patient reported outcome/experience measures (PROMs/PREMs) will be captured throughout the trial.
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