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Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic PreConditioning (RIPC) in Lymphoma patients receiving anthracyclines.
Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic PreConditioning (RIPC) in lymphoma patients receiving anthracyclines. Patients scheduled to undergo ≥5 chemotherapy cycles will be eligible. Patients fulfilling all inclusion and no exclusion criteria will be enrolled and undergo baseline Cardiac Magnetic Baseline (CMR), and high sensitivity troponin (hsTn) and NT-proBNP blood test. Patients with confirmed LVEF \>40% by CMR will be randomized 1:1 to RIPC vs simulated RIPC (Sham). After the third chemotherapy cycle, a second CMR+ hsTn/ NT-proBNP will be performed for the validation of the early marker of cardiotoxicity. A third hsTn/ NT-proBNP blood test will be performed in the last chemotherapy cycle. Nine weeks after finishing chemotherapy, a last CMR+ hsTn/ NT-proBNP will be performed. Patients will be followed-up for clinical events at 6, 12, 18, 30 and 42 months until the last patient undergoes the final CMR. When the last patient undergoes the third CMR, the follow-up will be closed. The median follow-up estimation for clinical endpoints is 36 months (range: 6 to 60 months).
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Aarhus University
Aarhus, Denmark
Hospital Jaques Monod, El Havre
Montivilliers, France
Henri Becquerel
Rouen, France
University Hospital Duesseldorf UDUS
Düsseldorf, Germany
Amsterdam UMC
Amsterdam, Netherlands
Hospital da Luz Learning Health (GLSMED)
Lisbon, Portugal
IPO Lisboa
Lisbon, Portugal
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Spain
Centro Medico Teknon
Barcelona, Spain
Instituto Catalán de Oncología
Barcelona, Spain
Start Date
January 18, 2022
Primary Completion Date
June 1, 2026
Completion Date
December 1, 2026
Last Updated
September 18, 2025
608
ESTIMATED participants
RIPC
DEVICE
Simulated RIPC (Sham)
DEVICE
Lead Sponsor
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Collaborators
NCT06337318
NCT06263491
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07388563