Summary
The increasing life expectancy of the population and the development of effective therapies result in a growing population of aged cancer survivors, which frequently have comorbidities for developing heart failure (HF). Anthracyclines (AC) are still first line treatment for many cancer types, but up to 35% of patients who received them develop cardiotoxicity and HF. 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 preconditioning) to reduce the incidence of AC-induced HF. We have selected Non-Hodgkin lymphoma as the target population, since it is diagnosed at advanced comorbid age in both genders. This will also allow us study gender differences in AC-induced HF. A phase II randomized clinical trial enrolling 608 patients undergoing AC chemotherapy will be done. Primary endpoint will be based on serial cardiac magnetic resonances 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 HF), responsible for a big proportion of healthcare expenditures.
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| Web resources: | https://cordis.europa.eu/project/id/945118 |
| Start date: | 01-06-2021 |
| End date: | 31-05-2026 |
| Total budget - Public funding: | 5 998 389,00 Euro - 5 998 388,00 Euro |
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Original description
The increasing life expectancy of the population and the development of effective therapies result in a growing population of aged cancer survivors, which frequently have comorbidities for developing heart failure (HF). Anthracyclines (AC) are still first line treatment for many cancer types, but up to 35% of patients who received them develop cardiotoxicity and HF. 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 preconditioning) to reduce the incidence of AC-induced HF. We have selected Non-Hodgkin lymphoma as the target population, since it is diagnosed at advanced comorbid age in both genders. This will also allow us study gender differences in AC-induced HF. A phase II randomized clinical trial enrolling 608 patients undergoing AC chemotherapy will be done. Primary endpoint will be based on serial cardiac magnetic resonances 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 HF), responsible for a big proportion of healthcare expenditures.Status
SIGNEDCall topic
SC1-BHC-08-2020Update Date
26-10-2022
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