RESILIENCE helps you survive cancer with a strong heart

Clinical Trial Synopsis

Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial to evaluate the benefits of remote ischemic conditioning in Non-Hodgkin lymphoma patients receiving anthracyclines.

RESILIENCE is a multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of weekly remote ischemic conditioning in Non-Hodgkin lymphoma (NHL) patients receiving anthracyclines.

Patients scheduled to undergo several chemotherapy cycles will be eligible. Patients fulfilling all inclusion and no exclusion criteria will be enrolled and undergo three Cardiac Magnetic Baseline studies before, during and after chemotherapy. Patients with confirmed LVEF >40% by CMR will be randomized 1:1 to remote ischemic conditioning vs simulated remote ischemic conditioning (Sham). Patients will be followed-up for clinical events. The median follow-up estimation for clinical endpoints is 24 months.

Summary of RESILIENCE clinical trial protocol

The primary endpoint of the trial is the absolute change in
CMR-based Left Ventricular Ejection Fraction.

Key secondary endpoints:
Rate of anthracycline-induced cardiotoxicity events, rate of arrhythmias, time to all cause death or heart failure hospitalization.

Patient reported outcome/experience measures (PROMs/PREMs) will be captured throughout the trial.

Logotipo Resilience

Are you a patient participating in RESILIENCE? Here you will find useful information about the details of your participation, activities specifically designed for you. You will also be able to contact RESILIENCE researchers.

In accordance with the provisions of Regulation (EU) 2016/679 on the protection of personal data of natural persons (GDPR), the personal information you have provided will be incorporated into the data processing systems of the Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.) for the purpose of attending your registration application in the restricted area for patients participating in the RESILIENCE study. The legal basis for processing your personal data for this purpose is your explicit consent. Your personal data will not be disclosed to any recipients other than those to whom you authorise or when required by law to do so. You may exercise your rights of access, right to rectification, to object, to erasure, to restriction of processing, data portability and not to be subject to automated individual decision-making. To exercise these rights, as well as to obtain additional information about the processing of your personal data, you can consult the following link Terms and Conditions