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 een internationale, prospectieve, proof-of-concept fase II, dubbelblinde, schijngecontroleerde, gerandomiseerde klinische studie (RCT) om de werkzaamheid en veiligheid te evalueren van wekelijkse ischemische conditionering op afstand bij patiënten met Lymfoom die antracyclines krijgen. Patiënten die gepland zijn om verschillende chemotherapiecycli te ondergaan, komen in aanmerking. Patiënten die aan alle inclusie- en geen exclusiecriteria voldoen, zullen worden ingeschreven en drie Cardiac Magnetic Baseline-onderzoeken ondergaan vóór, tijdens en na chemotherapie. Patiënten met een bevestigde LVEF >40% door CMR worden 1:1 gerandomiseerd naar ischemische conditionering op afstand versus gesimuleerde ischemische conditionering op afstand (Sham). Patiënten zullen worden gevolgd voor klinische gebeurtenissen. De mediane follow-up schatting voor klinische eindpunten is 24 maanden.
Belangrijkste secundaire eindpunten: frequentie van door antracycline geïnduceerde hartschade, frequentie van aritmieën, tijd tot overlijden of ziekenhuisopname voor hartfalen.
Door de patiënt gerapporteerde uitkomst-/ervaringsmaten (PROM’s/PREM’s) zullen gedurende de hele studie worden vastgelegd.
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