Periodic Reporting for period 2 - RESILIENCE (Remote Ischemic Conditioning in Lymphoma Patients Receiving Anthracyclines.)
Periodo di rendicontazione: 2022-12-01 al 2024-05-31
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.
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.
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
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
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.
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.