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.
The trade-off between cancer and chronic HF is of massive psychological burden for patients, and of devastating economic consequences for healthcare systems. We aim to test the efficacy of a novel intervention (remote ischemic conditioning) to reduce the incidence of anthracycline-induced heart failure. Patients with Lymphoma have been selected as the target population, since it is diagnosed at advanced comorbid age in both genders.
This will also allow the study of gender differences in anthracycline-induced heart failure. A phase II randomized clinical trial enrolling 608 patients undergoing chemotherapy with anthracyclines will be done. Primary endpoint will be based on serial cardiac magnetic resonance exams. Taking advantage of the recruited population and data gathered, we will further validate 2 novel cardiac magnetic resonance imaging methods: a novel early marker of cardiotoxicity, and a new sequence allowing a massive reduction of acquisition time.
We will also study a personalized strategy to empower patients in clinical trial execution, which includes Patient-Reported Outcome and Experience Measures (PROMs and PREMs). Our final goal is to reach the patient level by implementing the novel strategy at the clinical level while paving the way for a future large phase III trial. For this endeavour, we count on a multidisciplinary consortium, where different stakeholders of this process are part of the study, from scientists to industry, and from healthcare providers (physicians and nurses) to patients. RESILIENCE deals with 2 of the most frequent non-communicable diseases in Europe (cancer and heart failure), responsible for a big proportion of healthcare expenditures.
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