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.
According to the WHO, the incidence of cancer is expected to rise by about 70% over the next 20 years. Half of those diagnosed with cancer will survive for at least a decade, and this survival rate is expected to increase significantly in the future, leading to worsening burden of cancer-related complications experienced by the global population.
Significant advances in cancer therapy have greatly reduced mortality, with non-malignant comorbid conditions becoming important determinants of quality of life (QOL) and overall long-term survival. Cardiovascular diseases are major contributors to overall morbidity and mortality in cancer survivors. There is a link between Heart Failure and Cancer, as Heart Disease and Cancer share common risk factors in the aged populations and are further linked through toxicities in the cardiovascular system effects of contemporary cancer treatment.
From the 4 million new cancer cases diagnosed in Europe every year, >3 million receive anthracyclines (alone or in combination). Very recent data show that >35% of patients receiving anthracyclines will develop any form of cardiotoxicity. More importantly, 6% of all patients receiving anthracyclines (200.000 patients every year in Europe) will develop moderate to severe cardiotoxicity. The latter corresponds to severe chronic heart failure, which is associated with massive personal and societal burden. The prevalence of chronic heart failure in Europe secondary to cancer therapy-related cardiotoxicity is ≈1 million people.
In order to reduce the burden of chronic disability in cancer survivors, there is an urgent need to develop interventions able to prevent anthracycline-induced cardiotoxicity and subsequent heart failure.
Based on strong experimental data, RESILIENCE will test the hypothesis that weekly at-home remote ischemic conditioning will reduce the incidence of anthracycline-induced cardiotoxicity in Lymphoma patients receiving anthracyclines.
Besides the lack of therapies that can prevent AIC, there is another unmet clinical need in the field: the inaccuracy of current algorithms to early identify this process. Current approaches are based on the identification of cardiac contractile defects and/or detection of detection of circulating biomarkers of myocardial injury. However, when these methods are altered it is already late since structural cardiac damage is already present. The RESILIENCE project will take advantage of the population enrolled in the trial and will validate a novel marker based on magnetic resonance imaging. Strong experimental data suggest that this marker is altered long before structural damage to the heart is present, opening a new window of preventive medicine.
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