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Remote Ischemic Conditioning in Lymphoma Patients Receiving Anthracyclines.

Project description

Innovative strategy to prevent anthracycline-induced heart failure

The growing population of aged cancer survivors is frequently associated with heart failure (HF). Anthracyclines (AC) is the first line of treatment for many cancer types. However, a significant proportion of treated patients develop cardiotoxicity and HF, resulting in psychological impacts on patients and devastating economic consequences for healthcare systems. RESILIENCE will test the effects of an innovative intervention, remote ischaemic preconditioning, as a strategy for reducing the incidence of AC-induced HF. A randomised clinical trial will enrol 608 patients with Non-Hodgkin Lymphoma undergoing AC chemotherapy. In addition, two innovative cardiac magnetic resonance imaging methods will be validated: one for early diagnosis of AC-cardiotoxicity and another to reduce the discomfort of patients undergoing magnetic resonance imaging.

Objective

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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RIA - Research and Innovation action

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Call for proposal

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(opens in new window) H2020-SC1-BHC-2018-2020

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Coordinator

CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III (F.S.P.)
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 793 243,50
Address
CALLE MELCHOR FERNANDEZ ALMAGRO 3
28029 Madrid
Spain

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Research Organisations
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 793 243,50

Participants (17)

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