Remote Ischemic Conditioning in Lymphoma Patients Receiving Anthracyclines.

Información del proyecto

RESILIENCE

Identificador del acuerdo de subvención: 945118

DOI

10.3030/945118

Fecha de la firma de la CE 29 Enero 2021

Fecha de inicio 1 Junio 2021

Fecha de finalización 31 Mayo 2027

Financiado con arreglo a

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coste total

€ 5 998 388,00

Aportación de la UE

€ 5 998 388,00

Coordinado por

CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III (F.S.P.)
Spain

Periodic Reporting for period 3 - RESILIENCE (Remote Ischemic Conditioning in Lymphoma Patients Receiving Anthracyclines.)

Período documentado: 2024-06-01 hasta 2025-11-30

Resumen del contexto y de los objetivos generales del proyecto

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 Non-Hodgkin 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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

The governance bodies for the project are all established and active.
The clinical trial started enrolling patients in January 2022.
Magnetic Resonance Imaging studies are being performed according to a unique protocol.
Dissemination activities for all audiences (medical, scintific, patients and lay people) are being implemented

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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 Non-Hodgkin 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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